Boots-Celltech Diagnostics, Inc.
Medical device manufacturer in Berkshire, England, GB.
20510(k) clearances
0PMA approvals
0recalls
Device types
- LJC Enzyme Linked Immunoabsorbent Assay… 3
- CEP Radioimmunoassay, Luteinizing Hormone 2
- CGJ Radioimmunoassay, Follicle-Stimulating… 1
- LGC Enzyme Linked Immunoabsorbent Assay, Herpes… 1
- CEC Radioimmunoassay, Free Thyroxine 1
- GNX Antigens, Cf (Including Cf Control)… 1
- JLP Spectrophotometric Method, Pregnanediol 1
- JLM Isoenzymes, Electrophoretic… 1
- GQN Antigen, Cf (Including Cf Control)… 1
- JSM Culture Media, Non-Propagating Transport 1
- LJP Antiserum, Fluorescent, Chlamydia Trachomatis 1
- JLW Radioimmunoassay, Thyroid-Stimulating Hormone 1
- LIO Device, Specimen Collection 1
- CFT Radioimmunoassay, Prolactin (Lactogen) 1
- CFL Radioimmunoassay, Human Growth Hormone 1
- GQG Antigen, Cf (Including Cf Controls)… 1
- IWP Radiographic Protective Glove 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K871877 | Ideia Herpes Simplex Virus TestLGC · Traditional | 11/17/1989SE |
| K880799 | Modified Ideia Chlamydia TestLJC · Traditional | 12/08/1988SE |
| K880758 | Sucrosep Specific Immunoradiometric AssayCEP · Traditional | 04/18/1988SE |
| K874875 | Chemelia Free THYROXINE(FT4)/ENZYME Immuno. (Eia)CEC · Traditional | 03/24/1988SE |
| K872958 | Imagen Influenza Virus a and B TestmiGNX · Traditional | 02/24/1988SE |
| K872843 | Oveia (TM) Dual AnalyteJLP · Traditional | 02/02/1988SE |
| K873625 | Chemelia Enzyme Immunoassay for (TSH)JLM · Traditional | 10/20/1987SE |
| K872056 | Modified (Directions for Use) for Ideia(Tm) TestLJC · Traditional | 06/15/1987SE |
| K870602 | Imagen Herpes Simplex Virus (HSV) Typing TestGQN · Traditional | 05/08/1987SE |
| K864998 | Ideia(Tm) Chlamydia Specimen Collection KitJSM · Traditional | 04/20/1987SE |
| K864539 | Modified Imagen(Tm) Chlamydia TestLJP · Traditional | 03/12/1987SE |
| K862439 | Sucrosep Follicle Stimulating Hormone (FSH) IrmaCGJ · Traditional | 08/19/1986SE |
| K861966 | Modified Ideia Chlamydia TestLJC · Traditional | 08/19/1986SE |
| K862607 | Imagen(Tm) Chlamydia Specimen Collection KitLIO · Traditional | 08/04/1986SE |
| K861271 | Sucrosep Human Prolactin (HPR) IrmaCFT · Traditional | 06/27/1986SE |
| K860308 | Sucrosep Luteinizing Hormone (LH) IrmaCEP · Traditional | 03/17/1986SE |
| K860228 | Sucrosep Human Growth Hormone (HGH) IrmaCFL · Traditional | 02/28/1986SE |
| K854081 | Imagen Respiratory Syncytial Virus TestGQG · Traditional | 01/03/1986SE |
| K844683 | Imagen Chlamydia TestIWP · Traditional | 02/06/1985SE |
| K842593 | Sucrosep Thyroid Stimulating HormoneJLW · Traditional | 09/12/1984SE |