Lee Laboratories, Inc.
Grayson, GA, US
LEE LABORATORIES, INC. appears in FDA device records in Grayson, GA. FDA records list 16 510(k) clearances between and , 37 PMA records and one registered establishment. As of , FDA records show 18 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
2 namesFDA records resolved to Lee Laboratories, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- BD Diagnostic Systems510(k), PMA, recall
- BD Diagnostic Systems / Lee Laboratoriesrecall
510(k) clearance history
FDA records hold 16 510(k) clearances for Lee Laboratories, Inc. between 1997 and 2026. The busiest year on record is 1997, with 10. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1997 | 10 |
| 2003 | 5 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K260213 | BD BACTEC FXI Culture System | MDB | Substantially Equivalent | |
| K032518 | PASCO MIC AND MIC/ID PANELS, GEMIFLOXACIN (STREP) | JWY | Substantially Equivalent | |
| K032153 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEFOTAXIME 0.5-64 UG/ML | LON | Substantially Equivalent | |
| K032259 | PASCO MIC AND MIC/ID PANELS | JWY | Substantially Equivalent | |
| K031429 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MEROPENEM 0.25-16 UG/ML | LON | Substantially Equivalent | |
| K030091 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - NORFLOXACIN 0.25 - 16 UG/ML | LON | Substantially Equivalent | |
| K972396 | VISTA ANTIGEN BRUCELLA MELITENSIS | GSO | Substantially Equivalent | |
| K972395 | VISTA ANTIGEN SALMONELLA O GROUP D | GNC | Substantially Equivalent | |
| K972394 | VISTA ANTIGEN BRUCELLA ABORTUS | GSO | Substantially Equivalent | |
| K972392 | VISTA ANTIGEN SALMONELLA H A | GNC | Substantially Equivalent | |
| K972391 | VISTA ANTIGEN SALMONELLA H B | GNC | Substantially Equivalent | |
| K972390 | VISTA ANTIGEN SALMONELLA H C | GNC | Substantially Equivalent | |
| K972389 | VISTA ANTIGEN SALMONELLA H D | GNC | Substantially Equivalent | |
| K972388 | VISTA ANTIGEN SALMONELLA O GROUP C | GNC | Substantially Equivalent | |
| K972387 | VISTA ANTIGEN SALMONELLA O GROUP A | GNC | Substantially Equivalent | |
| K972386 | VISTA ANTIGEN SALMONELLA O GROUP B | GNC | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1025402 | 1025402 | LEE LABORATORIES, INC. | 1475 ATHENS HWY., GRAYSON, GA 30017 US | 2026 | and 3 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- GOXAntigen, B. Pertussis
- GSOAntigens (Febrile), Agglutination, Brucella Spp.
- GRLAntigens, All Groups, Salmonella Spp.
- GNCAntigens, Febrile, Slide And Tube, All Groups, Salmonella Spp.
- GOWAntisera, Agglutinating, B. Parapertussis
- GOYAntisera, Agglutinating, B. Pertussis, All
- GRMAntisera, All Groups, Salmonella Spp.
- GNAAntisera, All Types, Escherichia Coli
- GRPAntisera, All Types, H. Influenza
- GSHAntisera, All Types, Listeria Monocytogenes
- GNBAntisera, All Types, Shigella Spp.
- GSQAntiserum, Vibrio Cholerae, All Varieties
- JWYManual Antimicrobial Susceptibility Test Systems
- JTLPlasma, Coagulase, Human, Horse And Rabbit
- MKQProcessor, Cervical Cytology Slide, Automated
- MVUReagents, Specific, Analyte
- MDBSystem, Blood Culturing
- LONSystem, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1562-2008 | BD DifcoTM Neisseria Meningitidis Antiserum Group Y 241113, 1mL, in vials, which were labeled in part, 8019456 6250890 N. MEN. GP Y UNLABELED LYOPH, Becton, Dickinson and Company, Sparks, MD 21152. The product is packaged in 100 vial units For use in slide agglutination tests for serotyping Neisseria Meningitidis. | Exhibits cross reactivity with Neisseria meningitides Group W135 | Terminated | ||
| Z-1561-2008 | BD DifcoTM Neisseria Meningitidis Antisera Group Y 241113, 1mL, in vials, which were labeled in part, 8019456 6250890 N. MEN. GP Y UNLABELED LYOPH, Becton, Dickinson and Company, Sparks, MD 21152. The product is packaged in 100 vial units For use in slide agglutination tests for serotyping Neisseria Meningitidis. | Exhibits cross reactivity with Neisseria meningitides Group W135 | Terminated | ||
| Z-1560-2008 | BD DifcoTM Neisseria Meningitidis Antisera Group Y 228811, 1mL, in vials, which were labeled in part, 8019456 6250890 N. MEN. GP Y UNLABELED LYOPH, Becton, Dickinson and Company, Sparks, MD 21152. The product is packaged in 1 vial units. For use in slide agglutination tests for serotyping Neisseria Meningitidis. | Exhibits cross reactivity with Neisseria meningitides Group W135. | Terminated | ||
| Z-1559-2008 | BD DifcoTM Neisseria Meningitidis Antisera Group Y, 228811, 1mL, in vials, which were labeled in part, 8019456 6250890 N. MEN. GP Y UNLABELED LYOPH, Becton Dickinson and Company, Sparks, MD 21152. The product is packaged in 1 vial units. For use in slide agglutination tests for serotyping Neisseria Meningitidis. | Exhibits cross reactivity with Neisseria meningitides Group W135. | Terminated | ||
| Z-1319-2008 | DIFCO Laboratories, FA Streptococcus Group A, 5mL, Catalog Number: 223181, Lot number: 6122656, Exp: 20090705, in vitro diagnostic. | Incorrect result: The product exhibited decreased fluorescence when testing with the homologous control organism. | Terminated | ||
| Z-0323-05 | BD, Febrile Antigen Negative Control | Febrile Antigens and Control Antisera that were released prior to August 2003 contained the 12/2000 revised insert that had incorrect testing instructions. | Terminated | ||
| Z-0322-05 | BD, Brucella Postive Control Antiserum (AMS) | Febrile Antigens and Control Antisera that were released prior to August 2003 contained the 12/2000 revised insert that had incorrect testing instructions. | Terminated | ||
| Z-0321-05 | BD, Proteus Polyvalent Antiserum (OXK, OX2, OX19) | Febrile Antigens and Control Antisera that were released prior to August 2003 contained the 12/2000 revised insert that had incorrect testing instructions. | Terminated | ||
| Z-0320-05 | BD, Francisella tularensis Antigen | Febrile Antigens and Control Antisera that were released prior to August 2003 contained the 12/2000 revised insert that had incorrect testing instructions. | Terminated | ||
| Z-0319-05 | BD, Proteus OX19 Antigen | Febrile Antigens and Control Antisera that were released prior to August 2003 contained the 12/2000 revised insert that had incorrect testing instructions. | Terminated | ||
| Z-0318-05 | BD, Salmonella Flagellar Polyvalent Antiserum (a,b,d) | Febrile Antigens and Control Antisera that were released prior to August 2003 contained the 12/2000 revised insert that had incorrect testing instructions. | Terminated | ||
| Z-0317-05 | BD, Salmonella O Group B Antigen (1-4-5-12) | Febrile Antigens and Control Antisera that were released prior to August 2003 contained the 12/2000 revised insert that had incorrect testing instructions. | Terminated | ||
| Z-0316-05 | BD, Salmonella O Group A Antigen (1-2-12) | Febrile Antigens and Control Antisera that were released prior to August 2003 contained the 12/2000 revised insert that had incorrect testing instructions. | Terminated | ||
| Z-0315-05 | BD, Salmonella Flagellar d Antigen (Typhoid H) | Febrile Antigens and Control Antisera that were released prior to August 2003 contained the 12/2000 revised insert that had incorrect testing instructions. | Terminated | ||
| Z-0314-05 | BD, Brucella abortus Antigen | Febrile Antigens and Control Antisera that were released prior to August 2003 contained the 12/2000 revised insert that had incorrect testing instructions. | Terminated | ||
| Z-0313-05 | BD, Salmonella Somatic Polyvalent Antiserum (A,B,D) | Febrile Antigens and Control Antisera that were released prior to August 2003 contained the 12/2000 revised insert that had incorrect testing instructions. | Terminated | ||
| Z-0312-05 | BD, Salmonella O Group D Antigen (9-12) (Typhoid O) | Febrile Antigens and Control Antisera that were released prior to August 2003 contained the 12/2000 revised insert that had incorrect testing instructions. | Terminated | ||
| Z-0311-05 | BD, Brucella melitensis Antigen | Febrile Antigens and Control Antisera that were released prior to August 2003 contained the 12/2000 revised insert that had incorrect testing instructions. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain