Boots-Celltech Diagnostics, Inc.: FDA filings under this applicant name
FDA lists 20 510(k) clearances under the applicant name “Boots-Celltech Diagnostics, Inc.” (first 1984, latest 1989), across 17 product codes in 4 review panels. Median 510(k) review time under this name: 85 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LJC | Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group) | 3 | 3 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 2 | 2 |
| CEC | Radioimmunoassay, Free Thyroxine | 1 | 1 |
| CFL | Radioimmunoassay, Human Growth Hormone | 1 | 1 |
| CFT | Radioimmunoassay, Prolactin (Lactogen) | 1 | 1 |
| CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 1 | 1 |
| GNX | Antigens, Cf (Including Cf Control), Influenza Virus A, B, C | 1 | 1 |
| GQG | Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus | 1 | 1 |
| GQN | Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2 | 1 | 1 |
| IWP | Radiographic Protective Glove | 1 | 1 |
Plus 7 more product codes.
Review panels
- Microbiology (10)
- Clinical Chemistry (8)
- Hematology (1)
- Radiology (1)
Most recent Boots-Celltech Diagnostics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K871877 | IDEIA HERPES SIMPLEX VIRUS TEST | LGC | 1989-11-17 | 918 |
| K880799 | MODIFIED IDEIA CHLAMYDIA TEST | LJC | 1988-12-08 | 283 |
| K880758 | SUCROSEP SPECIFIC IMMUNORADIOMETRIC ASSAY | CEP | 1988-04-18 | 53 |
| K874875 | CHEMELIA FREE THYROXINE(FT4)/ENZYME IMMUNO. (EIA) | CEC | 1988-03-24 | 118 |
| K872958 | IMAGEN INFLUENZA VIRUS A AND B TESTMI | GNX | 1988-02-24 | 210 |
| K872843 | OVEIA (TM) DUAL ANALYTE | JLP | 1988-02-02 | 197 |
| K873625 | CHEMELIA ENZYME IMMUNOASSAY FOR (TSH) | JLM | 1987-10-20 | 42 |
| K872056 | MODIFIED (DIRECTIONS FOR USE) FOR IDEIA(TM) TEST | LJC | 1987-06-15 | 18 |
| K870602 | IMAGEN HERPES SIMPLEX VIRUS (HSV) TYPING TEST | GQN | 1987-05-08 | 86 |
| K864998 | IDEIA(TM) CHLAMYDIA SPECIMEN COLLECTION KIT | JSM | 1987-04-20 | 119 |
10 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Boots-Celltech Diagnostics, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Boots-Celltech Diagnostics, Inc. (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances are listed under Boots-Celltech Diagnostics, Inc.?
FDA lists 20 510(k) clearances under the applicant name “Boots-Celltech Diagnostics, Inc.” (first 1984, latest 1989), across 17 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Boots-Celltech Diagnostics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Boots-Celltech Diagnostics, Inc. is 85 days.
Which FDA product codes appear under Boots-Celltech Diagnostics, Inc.?
The most frequent FDA product codes under this applicant name are LJC (Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group), 3); CEP (Radioimmunoassay, Luteinizing Hormone, 2); CEC (Radioimmunoassay, Free Thyroxine, 1).
Next steps
- See all 20 Boots-Celltech Diagnostics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LJC, Boots-Celltech Diagnostics, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.