Biosafe Laboratories, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Biosafe Laboratories, Inc.” (first 1999, latest 2004), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 106 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 |
|---|---|---|---|
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 2 | 2 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 | 1 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | 1 | 1 |
| KHG | Whole Blood Hemoglobin Determination | 1 | 1 |
| LCP | Assay, Glycosylated Hemoglobin | 1 | 1 |
Review panels
- Clinical Chemistry (4)
- Hematology (2)
Most recent Biosafe Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K042379 | ANEMIAPRO SELF-SCREENER | KHG | 2004-12-15 | 105 |
| K012221 | SAFE AT HOME CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM | JKA | 2002-04-03 | 261 |
| K011970 | BIOSAFE CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM | CHH | 2001-09-26 | 93 |
| K011525 | SAFE AT HOME TSH (THYROID STIMULATING HORMONE BLOOD COLLECTION AND TRANSPORT SYSTEM) | JLW | 2001-07-16 | 60 |
| K003752 | BIOSAFE CAPILLARY BLOOD TRANSPORT SYSTEM FOR TESTING THYROID STIMULATING HORMONE (TSH) | JLW | 2001-03-23 | 108 |
| K991850 | SAFE AT-HOME TEST KIT FOR MONITORING HEMOGLOBIN ALC | LCP | 1999-11-26 | 178 |
Recalls
openFDA lists no recalls under a recalling firm named Biosafe Laboratories, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Biosafe Laboratories, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Biosafe Laboratories, Inc.” (first 1999, latest 2004), across 5 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 Biosafe Laboratories, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biosafe Laboratories, Inc. is 106 days.
Which FDA product codes appear under Biosafe Laboratories, Inc.?
The most frequent FDA product codes under this applicant name are JLW (Radioimmunoassay, Thyroid-Stimulating Hormone, 2); CHH (Enzymatic Esterase--Oxidase, Cholesterol, 1); JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection, 1).
Next steps
- See all 6 Biosafe Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JLW, Biosafe Laboratories, 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.