Baxter Diagnostics, Inc.
Miami, FL, US
Baxter Diagnostics, Inc. appears in FDA device records in Miami, FL. FDA records list 72 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 72
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 72FDA records hold 72 510(k) clearances for Baxter Diagnostics, Inc. between 1988 and 1995. The busiest year on record is 1992, with 25. The most recent is 1995, with 11.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1988 | 4 |
| 1991 | 4 |
| 1992 | 25 |
| 1993 | 17 |
| 1994 | 11 |
| 1995 | 11 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K934458 | DRIED GRAM-POSITIVE MIC/COMBO PANELS | JWY | Substantially Equivalent | |
| K950817 | DRIED GRAM POSITIVE MIC/COMBO PANELS/PNEUMOCOCCI | JWY | Substantially Equivalent | |
| K935704 | DRIED GRAM-NEGATIVE MIC//COMBO PANELS | LTT | Substantially Equivalent | |
| K950570 | STRATUS PROGESTERONE FLUOROMETRIC ENZYME IMMUNOASSAY | JLS | Substantially Equivalent | |
| K945235 | DRIED GRAM-POSITIVE MIC/COMBO PANELS | LTT | Substantially Equivalent | |
| K941030 | DRIED GRAM-NEGATIVE CEFPODOXIME | LTT | Substantially Equivalent | |
| K940917 | LORACARBEF GRAM-NAGATIVE PANELS | JWY | Substantially Equivalent | |
| K941459 | GRAM POSITIVE DRIED OVERNIGHT PANELS/LOMEFLOX | JWY | Substantially Equivalent | |
| K941317 | DRIED GRAM NEGATIVE/CEFMETAZOLE | JWY | Substantially Equivalent | |
| K942267 | DRIED GRAM-POSITIVE MIC/COMBO PANELS/CEFMETAZOLE | JWY | Substantially Equivalent | |
| K942089 | MICRODILUTION/LORACARBEF PANELS | JWY | Substantially Equivalent | |
| K943510 | DRIED GRAM-POSITIVE MIC/COMBO PANELS | JWY | Substantially Equivalent | |
| K935702 | DADE INNOVIN II | GJS | Substantially Equivalent | |
| K935307 | DADE(R) THROMBIN-ANTITHROMBIN (TAT) COMPLEX ELISA | DDQ | Substantially Equivalent | |
| K934003 | STRATUS DIGOXIN FLOUROMETRIC ENZYME IMMUNOASSAY | DKA | Substantially Equivalent | |
| K933414 | STRATUS(R) THYROID UPTAKE FLUOR ENZYME IMMUNOASSAY | KHQ | Substantially Equivalent | |
| K944651 | DRIED GRAM-POSITIVE MIC/COMBO PANELS | JWY | Substantially Equivalent | |
| K934323 | DRIED GRAM-POSITIVE MIC/COMBO PANELS, AMP/EXT DIL | JWY | Substantially Equivalent | |
| K935987 | FLEXTRANS | JSM | Substantially Equivalent | |
| K936196 | ANTITHROMBIN III CHROMOGENIC ASSAY | JBQ | Substantially Equivalent | |
| K934275 | PARAMAX ALCOHOL REAGENT | DIC | Substantially Equivalent | |
| K935568 | PARAMAX PHENOBARBITAL REAGENT AND CALIBRATORS | DLZ | Substantially Equivalent | |
| K932686 | PARAMAX(R) PHENYTOIN REAGENT | DIP | Substantially Equivalent | |
| K933437 | DADE ANEMIA/HEMOCHROMATOSIS CONTOLS,LEVEL 1,LEVEL 2,AND LEVEL 3 | JJY | Substantially Equivalent | |
| K932912 | STRATUS FREE THYROXINE (FREE T4) FLUOROMETRIC | CEC | Substantially Equivalent | |
| K933464 | STRATUS ESTRADIOL FLUOROMETRIC ENZYME IMMUNOASSAY | CHP | Substantially Equivalent | |
| K933635 | STRATUS PROGESTERONE FLOUROMETRIC IMMUNOASSAY | JLS | Substantially Equivalent | |
| K933435 | DADE URINE CHEMISTRY CONTROL, LEVEL 1 & LEVEL 2 | JJY | Substantially Equivalent | |
| K932685 | PARAMAX(R) THEOPHYLLINE REAGENT AND CALIBRATORS | KLS | Substantially Equivalent | |
| K933188 | DADE (PAI-1) CHROMOGENIC ASSAY DADE COAGTROL-PAI | JPA | Substantially Equivalent | |
| K933426 | STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNO | CDX | Substantially Equivalent | |
| K924919 | DADE(R) TUMOR MARKER CONTROL | JJY | Substantially Equivalent | |
| K932082 | DRIED GRAM-NEGATIVE MIC/COMBO PANELS | JWY | Substantially Equivalent | |
| K922582 | BARTELS CYTOMEGALOVIRUS IGG EIA | LFZ | Substantially Equivalent | |
| K922580 | BARTELS CYTOMEGALOVIRUS IGM EIA | LKQ | Substantially Equivalent | |
| K926545 | DRIED GRAM-NEGATIVE MIC/COMBO PANELS | JWY | Substantially Equivalent | |
| K922482 | MICROSCAN DRI GRAM POSIT/GRAM NEGA MIC/COMBO PANEL | LRG | Substantially Equivalent | |
| K925452 | DADE HEPZYME | JBR | Substantially Equivalent | |
| K926046 | DADE(R) CK-MB/MYOGLOBIN IMMUN CONTROL, I,II,III | JJY | Substantially Equivalent | |
| K922334 | BARTELS HERPES SIMPLEX VIRUS 1 IGM EIA | LGC | Substantially Equivalent | |
| K922333 | BARTELS HERPES SIMPLEX VIRUS 2 IGM EIA | LGC | Substantially Equivalent | |
| K924074 | STRATUS VITAMIN B12 FLUOROMETRIC ENZYME-LINKED | CDD | Substantially Equivalent | |
| K922073 | STRATUS BHCG FLUOROMETRIC ENZYME IMMUNOASSAY | DHA | Substantially Equivalent | |
| K922583 | BARTELS HERPES SIMPLEX VIRUS 2 IGG EIA | LGC | Substantially Equivalent | |
| K922584 | BARTELS HERPES SIMPLEX VIRUS 1 IGG EIA | LGC | Substantially Equivalent | |
| K923286 | STRATUS FOLATE FLUOROMETRIC ENZYME-LINKED ASSAY | CGN | Substantially Equivalent | |
| K922586 | BARTELS RUBELLA IGG EIA | LFX | Substantially Equivalent | |
| K922581 | BARTELS RUBELLA IGM EIA | LFX | Substantially Equivalent | |
| K922585 | BARTELS TOXOPLASMA IGG EIA | LGD | Substantially Equivalent | |
| K922579 | BARTELS TOXOPLASMA IGM EIA | LGD | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- CGNAcid, Folic, Radioimmunoassay
- DICAlcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
- LJNAntibody Igm, If, Epstein-Barr Virus
- LKQAntibody Igm,If, Cytomegalovirus Virus
- DDQAntigen, Antiserum, Control, Antithrombin Iii
- GNXAntigens, Cf (Including Cf Control), Influenza Virus A, B, C
- GQSAntigens, Cf (Including Cf Control), Parainfluenza Virus 1-4
- DKAAntiserum, Digoxin
- JBQAntithrombin Iii Quantitation
- MSJApolipoproteins
- JJQColorimeter, Photometer, Spectrophotometer For Clinical Use
- JSMCulture Media, Non-Propagating Transport
- DIPEnzyme Immunoassay, Diphenylhydantoin
- DLZEnzyme Immunoassay, Phenobarbital
- KLSEnzyme Immunoassay, Theophylline
- LJCEnzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)
- LFZEnzyme Linked Immunoabsorbent Assay, Cytomegalovirus
- LGCEnzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific
- LFXEnzyme Linked Immunoabsorbent Assay, Rubella
- LJBEnzyme Linked Immunoabsorbent Assay, Rubeola Igg
- LGDEnzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
- LSEEpstein-Barr Virus, Other
- JMOFerrozine (Colorimetric) Iron Binding Capacity
- LRGInstrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
- JWYManual Antimicrobial Susceptibility Test Systems
- JJYMulti-Analyte Controls, All Kinds (Assayed)
- DDRMyoglobin, Antigen, Antiserum, Control
- LTTPanels, Test, Susceptibility, Antimicrobial
- GJTPlasma, Coagulation Factor Deficient
- MIFProthrombin Fragment 1.2
- KHQRadioassay, Triiodothyronine Uptake
- CDDRadioassay, Vitamin B12
- CHPRadioimmunoassay, Estradiol
- CECRadioimmunoassay, Free Thyroxine
- JLSRadioimmunoassay, Progesterone
- CDXRadioimmunoassay, Total Thyroxine
- LSRReagent, Borrelia Serological Reagent
- LLHReagents, Clostridium Difficile Toxin
- LKTRespiratory Syncytial Virus, Antigen, Antibody, Ifa
- JPASystem, Multipurpose For In Vitro Coagulation Studies
- DHASystem, Test, Human Chorionic Gonadotropin
- JBRTest, Heparin Neutralization
- GGPTest, Qualitative And Quantitative Factor Deficiency
- GJSTest, Time, Prothrombin
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain