Bioclinical Laboratory Services, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Bioclinical Laboratory Services, Inc.” (first 1987, latest 1987), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 75 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 |
|---|---|---|---|
| KIT | Media And Components, Synthetic Cell And Tissue Culture | 3 | 3 |
| LYX | Media, Corneal Storage | 3 | 3 |
Review panels
- Ophthalmic (3)
- Pathology (3)
Most recent Bioclinical Laboratory Services, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K870451 | SKIN GRAFT PRESERVATION MEDIUM (TISSUE) | KIT | 1987-05-26 | 112 |
| K870251 | CHONDROITIN SULFATE CORNEAL STORAGE MEDIUM | LYX | 1987-04-06 | 75 |
| K870250 | MODIFIED MCCAREY-KAUFMAN CORNEAL STORAGE MEDIUM | LYX | 1987-04-06 | 75 |
| K870249 | MCCAREY-KAUFMAN CORNEAL STORAGE MEDIUM | LYX | 1987-04-06 | 75 |
| K864396 | LYMPHOCYTE MAINTENANCE MEDIUM | KIT | 1987-02-02 | 88 |
| K864740 | BONE MARROW COLLECTION MEDIUM | KIT | 1987-01-05 | 32 |
Recalls
openFDA lists no recalls under a recalling firm named Bioclinical Laboratory Services, 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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Bioclinical Systems, Inc. (13 510(k)s)
- Bioclinical Group (9 510(k)s)
- Bioclinical Corp. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Bioclinical Laboratory Services, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Bioclinical Laboratory Services, Inc.” (first 1987, latest 1987), across 2 product codes in 2 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 Bioclinical Laboratory Services, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bioclinical Laboratory Services, Inc. is 75 days.
Which FDA product codes appear under Bioclinical Laboratory Services, Inc.?
The most frequent FDA product codes under this applicant name are KIT (Media And Components, Synthetic Cell And Tissue Culture, 3); LYX (Media, Corneal Storage, 3).
Next steps
- See all 6 Bioclinical Laboratory Services, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KIT, Bioclinical Laboratory Services, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.