Company ยท GB
Boots-Celltech Diagnostics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1984 to 1989. Name variants (Inc, Corp, punctuation) are merged.
20510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LJC | Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group) | 3 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 2 |
| CEC | Radioimmunoassay, Free Thyroxine | 1 |
| CFL | Radioimmunoassay, Human Growth Hormone | 1 |
| CFT | Radioimmunoassay, Prolactin (Lactogen) | 1 |
| CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 1 |
| GNX | Antigens, Cf (Including Cf Control), Influenza Virus A, B, C | 1 |
| GQG | Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus | 1 |
| GQN | Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2 | 1 |
| IWP | Radiographic Protective Glove | 1 |
| JLM | Isoenzymes, Electrophoretic, Glucose-6-Phosphate Dehydrogenase | 1 |
| JLP | Spectrophotometric Method, Pregnanediol | 1 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 1 |
| JSM | Culture Media, Non-Propagating Transport | 1 |
| LGC | Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific | 1 |
| LIO | Device, Specimen Collection | 1 |
| LJP | Antiserum, Fluorescent, Chlamydia Trachomatis | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 17, 1989 | K871877 | IDEIA HERPES SIMPLEX VIRUS TEST Boots-Celltech Diagnostics, Inc., GB | LGC |
| Dec 8, 1988 | K880799 | MODIFIED IDEIA CHLAMYDIA TEST Boots-Celltech Diagnostics, Inc. | LJC |
| Apr 18, 1988 | K880758 | SUCROSEP SPECIFIC IMMUNORADIOMETRIC ASSAY Boots-Celltech Diagnostics, Inc., GB | CEP |
| Mar 24, 1988 | K874875 | CHEMELIA FREE THYROXINE(FT4)/ENZYME IMMUNO. (EIA) Boots-Celltech Diagnostics, Inc. | CEC |
| Feb 24, 1988 | K872958 | IMAGEN INFLUENZA VIRUS A AND B TESTMI Boots-Celltech Diagnostics, Inc., GB | GNX |
| Feb 2, 1988 | K872843 | OVEIA (TM) DUAL ANALYTE Boots-Celltech Diagnostics, Inc., GB | JLP |
| Oct 20, 1987 | K873625 | CHEMELIA ENZYME IMMUNOASSAY FOR (TSH) Boots-Celltech Diagnostics, Inc., GB | JLM |
| Jun 15, 1987 | K872056 | MODIFIED (DIRECTIONS FOR USE) FOR IDEIA(TM) TEST Boots-Celltech Diagnostics, Inc., GB | LJC |
| May 8, 1987 | K870602 | IMAGEN HERPES SIMPLEX VIRUS (HSV) TYPING TEST Boots-Celltech Diagnostics, Inc., GB | GQN |
| Apr 20, 1987 | K864998 | IDEIA(TM) CHLAMYDIA SPECIMEN COLLECTION KIT Boots-Celltech Diagnostics, Inc., GB | JSM |
| Mar 12, 1987 | K864539 | MODIFIED IMAGEN(TM) CHLAMYDIA TEST Boots-Celltech Diagnostics, Inc., GB | LJP |
| Aug 19, 1986 | K862439 | SUCROSEP FOLLICLE STIMULATING HORMONE (FSH) IRMA Boots-Celltech Diagnostics, Inc., GB | CGJ |
| Aug 19, 1986 | K861966 | MODIFIED IDEIA CHLAMYDIA TEST Boots-Celltech Diagnostics, Inc., GB | LJC |
| Aug 4, 1986 | K862607 | IMAGEN(TM) CHLAMYDIA SPECIMEN COLLECTION KIT Boots-Celltech Diagnostics, Inc., GB | LIO |
| Jun 27, 1986 | K861271 | SUCROSEP HUMAN PROLACTIN (HPR) IRMA Boots-Celltech Diagnostics, Inc., GB | CFT |
| Mar 17, 1986 | K860308 | SUCROSEP LUTEINIZING HORMONE (LH) IRMA Boots-Celltech Diagnostics, Inc., GB | CEP |
| Feb 28, 1986 | K860228 | SUCROSEP HUMAN GROWTH HORMONE (HGH) IRMA Boots-Celltech Diagnostics, Inc., GB | CFL |
| Jan 3, 1986 | K854081 | IMAGEN RESPIRATORY SYNCYTIAL VIRUS TEST Boots-Celltech Diagnostics, Inc., GB | GQG |
| Feb 6, 1985 | K844683 | IMAGEN CHLAMYDIA TEST Boots-Celltech Diagnostics, Inc., GB | IWP |
| Sep 12, 1984 | K842593 | SUCROSEP THYROID STIMULATING HORMONE Boots-Celltech Diagnostics, Inc. | JLW |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||