Boots-Celltech Diagnostics, Inc.
FDA 510(k) & PMA Approved Devices — 20 products
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Total Devices20
Categories0
Latest FDA decision
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K871877 | IDEIA HERPES SIMPLEX VIRUS TEST | LGC | 1989-11-17 | View |
| 510(k) | K880799 | MODIFIED IDEIA CHLAMYDIA TEST | LJC | 1988-12-08 | View |
| 510(k) | K880758 | SUCROSEP SPECIFIC IMMUNORADIOMETRIC ASSAY | CEP | 1988-04-18 | View |
| 510(k) | K874875 | CHEMELIA FREE THYROXINE(FT4)/ENZYME IMMUNO. (EIA) | CEC | 1988-03-24 | View |
| 510(k) | K872958 | IMAGEN INFLUENZA VIRUS A AND B TESTMI | GNX | 1988-02-24 | View |
| 510(k) | K872843 | OVEIA (TM) DUAL ANALYTE | JLP | 1988-02-02 | View |
| 510(k) | K873625 | CHEMELIA ENZYME IMMUNOASSAY FOR (TSH) | JLM | 1987-10-20 | View |
| 510(k) | K872056 | MODIFIED (DIRECTIONS FOR USE) FOR IDEIA(TM) TEST | LJC | 1987-06-15 | View |
| 510(k) | K870602 | IMAGEN HERPES SIMPLEX VIRUS (HSV) TYPING TEST | GQN | 1987-05-08 | View |
| 510(k) | K864998 | IDEIA(TM) CHLAMYDIA SPECIMEN COLLECTION KIT | JSM | 1987-04-20 | View |
| 510(k) | K864539 | MODIFIED IMAGEN(TM) CHLAMYDIA TEST | LJP | 1987-03-12 | View |
| 510(k) | K862439 | SUCROSEP FOLLICLE STIMULATING HORMONE (FSH) IRMA | CGJ | 1986-08-19 | View |
| 510(k) | K861966 | MODIFIED IDEIA CHLAMYDIA TEST | LJC | 1986-08-19 | View |
| 510(k) | K862607 | IMAGEN(TM) CHLAMYDIA SPECIMEN COLLECTION KIT | LIO | 1986-08-04 | View |
| 510(k) | K861271 | SUCROSEP HUMAN PROLACTIN (HPR) IRMA | CFT | 1986-06-27 | View |
| 510(k) | K860308 | SUCROSEP LUTEINIZING HORMONE (LH) IRMA | CEP | 1986-03-17 | View |
| 510(k) | K860228 | SUCROSEP HUMAN GROWTH HORMONE (HGH) IRMA | CFL | 1986-02-28 | View |
| 510(k) | K854081 | IMAGEN RESPIRATORY SYNCYTIAL VIRUS TEST | GQG | 1986-01-03 | View |
| 510(k) | K844683 | IMAGEN CHLAMYDIA TEST | IWP | 1985-02-06 | View |
| 510(k) | K842593 | SUCROSEP THYROID STIMULATING HORMONE | JLW | 1984-09-12 | View |
No matching devices.
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