Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Boots-Celltech Diagnostics, Inc. — Predicate Candidate Screening
20 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
86 daysmedian FDA review time
283 days90th percentile
20clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K871877 | IDEIA HERPES SIMPLEX VIRUS TEST | Boots-Celltech Diagnostics, Inc. | 1989-11-17 | 918 | 0 |
| K880799 | MODIFIED IDEIA CHLAMYDIA TEST | Boots-Celltech Diagnostics, Inc. | 1988-12-08 | 283 | 0 |
| K880758 | SUCROSEP SPECIFIC IMMUNORADIOMETRIC ASSAY | Boots-Celltech Diagnostics, Inc. | 1988-04-18 | 53 | 0 |
| K874875 | CHEMELIA FREE THYROXINE(FT4)/ENZYME IMMUNO. (EIA) | Boots-Celltech Diagnostics, Inc. | 1988-03-24 | 118 | 0 |
| K872958 | IMAGEN INFLUENZA VIRUS A AND B TESTMI | Boots-Celltech Diagnostics, Inc. | 1988-02-24 | 210 | 0 |
| K872843 | OVEIA (TM) DUAL ANALYTE | Boots-Celltech Diagnostics, Inc. | 1988-02-02 | 197 | 0 |
| K873625 | CHEMELIA ENZYME IMMUNOASSAY FOR (TSH) | Boots-Celltech Diagnostics, Inc. | 1987-10-20 | 42 | 0 |
| K872056 | MODIFIED (DIRECTIONS FOR USE) FOR IDEIA(TM) TEST | Boots-Celltech Diagnostics, Inc. | 1987-06-15 | 18 | 0 |
| K870602 | IMAGEN HERPES SIMPLEX VIRUS (HSV) TYPING TEST | Boots-Celltech Diagnostics, Inc. | 1987-05-08 | 86 | 0 |
| K864998 | IDEIA(TM) CHLAMYDIA SPECIMEN COLLECTION KIT | Boots-Celltech Diagnostics, Inc. | 1987-04-20 | 119 | 0 |
| K864539 | MODIFIED IMAGEN(TM) CHLAMYDIA TEST | Boots-Celltech Diagnostics, Inc. | 1987-03-12 | 113 | 0 |
| K861966 | MODIFIED IDEIA CHLAMYDIA TEST | Boots-Celltech Diagnostics, Inc. | 1986-08-19 | 91 | 0 |
| K862439 | SUCROSEP FOLLICLE STIMULATING HORMONE (FSH) IRMA | Boots-Celltech Diagnostics, Inc. | 1986-08-19 | 54 | 0 |
| K862607 | IMAGEN(TM) CHLAMYDIA SPECIMEN COLLECTION KIT | Boots-Celltech Diagnostics, Inc. | 1986-08-04 | 27 | 0 |
| K861271 | SUCROSEP HUMAN PROLACTIN (HPR) IRMA | Boots-Celltech Diagnostics, Inc. | 1986-06-27 | 84 | 0 |
| K860308 | SUCROSEP LUTEINIZING HORMONE (LH) IRMA | Boots-Celltech Diagnostics, Inc. | 1986-03-17 | 48 | 0 |
| K860228 | SUCROSEP HUMAN GROWTH HORMONE (HGH) IRMA | Boots-Celltech Diagnostics, Inc. | 1986-02-28 | 37 | 0 |
| K854081 | IMAGEN RESPIRATORY SYNCYTIAL VIRUS TEST | Boots-Celltech Diagnostics, Inc. | 1986-01-03 | 88 | 0 |
| K844683 | IMAGEN CHLAMYDIA TEST | Boots-Celltech Diagnostics, Inc. | 1985-02-06 | 68 | 0 |
| K842593 | SUCROSEP THYROID STIMULATING HORMONE | Boots-Celltech Diagnostics, Inc. | 1984-09-12 | 71 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda