Bartels Immunodiagnostic Supplies, Inc.
Mchenry, IL, US
Bartels Immunodiagnostic Supplies, Inc. appears in FDA device records in Mchenry, IL. FDA records list 35 510(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
- 35
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 35 510(k) clearances for Bartels Immunodiagnostic Supplies, Inc. between 1981 and 1986. The busiest year on record is 1984, with 27. The most recent is 1986, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1981 | 1 |
| 1982 | 1 |
| 1984 | 27 |
| 1985 | 2 |
| 1986 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K864776 | A549 (HUMAN LUNG CARCINOMA) CULTURE CELLS | KIR | Substantially Equivalent | |
| K861172 | ROTAVIRUS LATEX AGGLUTINATION ASSAY | LIQ | Substantially Equivalent | |
| K860279 | CYTOMEGALOVIRUS DIRECT FLUORESCENT ANTIBODY KIT | LIN | Substantially Equivalent | |
| K855034 | AMERICAN HISTO-ID SYS PRIMARY KIT PSA PROSTATE ANT | LIJ | Substantially Equivalent | |
| K842830 | IMMUNOPER-OXIDASE TEST KIT FOR DETECT OF | GQN | Substantially Equivalent | |
| K852185 | RESPIRATORY SYNCYTIAL VIRUS DIRECT FLUORESCENT ANT | LKT | Substantially Equivalent | |
| K844105 | FITC LABELED CHLAMYDIAE MONOCLONAL ANTIBODY | Substantially Equivalent | ||
| K842834 | HEP-2 CELLS | KJR | Substantially Equivalent | |
| K842833 | PMK PRIMARY MONKEY KIDNEY-CELLS | KJR | Substantially Equivalent | |
| K842328 | AMER. HISTO-ID SYS PRIMARY LAMBDA CHAIN | DEH | Substantially Equivalent | |
| K842330 | AMER. HISTO-ID SYS PRIMARY IGA 2720-21 | CZP | Substantially Equivalent | |
| K842329 | AMER. HISTO-ID SYS PRIMARY IGG S7920-11 | DEW | Substantially Equivalent | |
| K842327 | AMER. HISTO-ID SYS PRIMARY IGM S7920-31 | DFT | Substantially Equivalent | |
| K842326 | AMER. HISTO-ID SYS PRIMARY KIT | DFH | Substantially Equivalent | |
| K842151 | CHLAMYDIAE IMMUNOPEROXIDASE TEST KIT | LKH | Substantially Equivalent | |
| K841998 | IMR-90-DIPLOID-HUMAN FETAL LUNG CELL | KIR | Substantially Equivalent | |
| K842000 | PRIMARY RABBITT KIDNEY CELL CULTURE | KIR | Substantially Equivalent | |
| K841999 | BGM CELL CULTURE AFRICAN GREEN MONKEY | KIR | Substantially Equivalent | |
| K840744 | TRANSPORTER VIRAL TRANSPORT MEDIUM | KIT | Substantially Equivalent | |
| K833447 | CYTOTOXICITY ASSAY FOR CLOSTRIDIUM- | MCB | Substantially Equivalent | |
| K834116 | DEAE-DEXTRAN IN PBS | KIT | Substantially Equivalent | |
| K834115 | CULTROL-ANTIBIOTIC/ANTIMYCOTIC SOLUT | JSK | Substantially Equivalent | |
| K834113 | TISSUE CULTURE REFEEDING MEDIUM | KIT | Substantially Equivalent | |
| K834136 | PBS W/MG+2 & CA+2 | KIT | Substantially Equivalent | |
| K834126 | MRC-5 CELLS | KIR | Substantially Equivalent | |
| K834124 | VERO CELLS | KIR | Substantially Equivalent | |
| K834123 | WI-38 HUMAN LUNG CELLS | KIR | Substantially Equivalent | |
| K834120 | LLC-MK2-RHESUS MONKEY KIDNEY CELLS | KIR | Substantially Equivalent | |
| K834119 | MCCOY CELLS | KIR | Substantially Equivalent | |
| K834117 | HUMAN FIBROBLASTIC CELLS-HUMAN NEWBORN | KIR | Substantially Equivalent | |
| K840851 | VIRAL TRANSPORT MEDIUM | Unknown | ||
| K834125 | CHLAMYDIAL TRANSPORT MEDIUM | JSM | Substantially Equivalent | |
| K834122 | CHLAMYDIAE ISOLATION MEDIUM W/CYCLOHEX | KIT | Substantially Equivalent | |
| K820895 | CYLOMEGALOVIRUS DIRECT FLUORESCENT ANTI | LIN | Substantially Equivalent | |
| K810856 | DIRECT IMMUNOFLUOR. ANTIBODY TEST KIT | GPT | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- MCBAntigen, C. Difficile
- GQNAntigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2
- LINAntisera, Conjugated Fluorescent, Cytomegalovirus
- LKHAntisera, Immunoperoxidase, Chlamydia Spp.
- GPTAntiserum, Cf, Psittacosis (Chlamydia Group)
- KIRCells, Animal And Human, Cultured
- JSMCulture Media, Non-Propagating Transport
- LIQEnzyme Linked Immunoabsorbent Assay, Rotavirus
- KJRErythrosin B
- CZPIga, Antigen, Antiserum, Control
- DEWIgg, Antigen, Antiserum, Control
- DFTIgm, Antigen, Antiserum, Control
- DFHKappa, Antigen, Antiserum, Control
- DEHLambda, Antigen, Antiserum, Control
- KITMedia And Components, Synthetic Cell And Tissue Culture
- LIJPeroxidase Anti-Peroxidase Immunohistochemical Stain
- LKTRespiratory Syncytial Virus, Antigen, Antibody, Ifa
- JSKSupplement, Culture Media
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