Boots-Celltech Diagnostics, Inc.
Walker, MI, US
Boots-Celltech Diagnostics, Inc. appears in FDA device records in Walker, MI. FDA records list 20 510(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
- 20
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 20 510(k) clearances for Boots-Celltech Diagnostics, Inc. between 1984 and 1989. The busiest year on record is 1986, with 7. The most recent is 1989, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1984 | 1 |
| 1985 | 1 |
| 1986 | 7 |
| 1987 | 5 |
| 1988 | 5 |
| 1989 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K871877 | IDEIA HERPES SIMPLEX VIRUS TEST | LGC | Substantially Equivalent | |
| K880799 | MODIFIED IDEIA CHLAMYDIA TEST | LJC | Substantially Equivalent | |
| K880758 | SUCROSEP SPECIFIC IMMUNORADIOMETRIC ASSAY | CEP | Substantially Equivalent | |
| K874875 | CHEMELIA FREE THYROXINE(FT4)/ENZYME IMMUNO. (EIA) | CEC | Substantially Equivalent | |
| K872958 | IMAGEN INFLUENZA VIRUS A AND B TESTMI | GNX | Substantially Equivalent | |
| K872843 | OVEIA (TM) DUAL ANALYTE | JLP | Substantially Equivalent | |
| K873625 | CHEMELIA ENZYME IMMUNOASSAY FOR (TSH) | JLM | Substantially Equivalent | |
| K872056 | MODIFIED (DIRECTIONS FOR USE) FOR IDEIA(TM) TEST | LJC | Substantially Equivalent | |
| K870602 | IMAGEN HERPES SIMPLEX VIRUS (HSV) TYPING TEST | GQN | Substantially Equivalent | |
| K864998 | IDEIA(TM) CHLAMYDIA SPECIMEN COLLECTION KIT | JSM | Substantially Equivalent | |
| K864539 | MODIFIED IMAGEN(TM) CHLAMYDIA TEST | LJP | Substantially Equivalent | |
| K862439 | SUCROSEP FOLLICLE STIMULATING HORMONE (FSH) IRMA | CGJ | Substantially Equivalent | |
| K861966 | MODIFIED IDEIA CHLAMYDIA TEST | LJC | Substantially Equivalent | |
| K862607 | IMAGEN(TM) CHLAMYDIA SPECIMEN COLLECTION KIT | LIO | Substantially Equivalent | |
| K861271 | SUCROSEP HUMAN PROLACTIN (HPR) IRMA | CFT | Substantially Equivalent | |
| K860308 | SUCROSEP LUTEINIZING HORMONE (LH) IRMA | CEP | Substantially Equivalent | |
| K860228 | SUCROSEP HUMAN GROWTH HORMONE (HGH) IRMA | CFL | Substantially Equivalent | |
| K854081 | IMAGEN RESPIRATORY SYNCYTIAL VIRUS TEST | GQG | Substantially Equivalent | |
| K844683 | IMAGEN CHLAMYDIA TEST | IWP | Substantially Equivalent | |
| K842593 | SUCROSEP THYROID STIMULATING HORMONE | JLW | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- GQNAntigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2
- GQGAntigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
- GNXAntigens, Cf (Including Cf Control), Influenza Virus A, B, C
- LJPAntiserum, Fluorescent, Chlamydia Trachomatis
- JSMCulture Media, Non-Propagating Transport
- LIODevice, Specimen Collection
- LJCEnzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)
- LGCEnzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific
- JLMIsoenzymes, Electrophoretic, Glucose-6-Phosphate Dehydrogenase
- IWPRadiographic Protective Glove
- CGJRadioimmunoassay, Follicle-Stimulating Hormone
- CECRadioimmunoassay, Free Thyroxine
- CFLRadioimmunoassay, Human Growth Hormone
- CEPRadioimmunoassay, Luteinizing Hormone
- CFTRadioimmunoassay, Prolactin (Lactogen)
- JLWRadioimmunoassay, Thyroid-Stimulating Hormone
- JLPSpectrophotometric Method, Pregnanediol
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain