Biotest Medical Corp.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Biotest Medical Corp.” (first 2009, latest 2017), across 1 product code in 1 review panel. Median 510(k) review time under this name: 96 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 | 2 | 238 |
| 2014 | 1 | 99 |
| 2015 | 1 | 362 |
| 2016 | 0 | — |
| 2017 | 2 | 92 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Biotest Medical Corp. took a median 92 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 223 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NBW | System, Test, Blood Glucose, Over The Counter | 10 | 10 |
Review panels
- Clinical Chemistry (10)
Most recent Biotest Medical Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K171822 | NuvoMed Wireless Blood Glucose Monitoring System (Model BGM-6/0352) | NBW | 2017-09-20 | 93 |
| K171785 | WowGoHealth Blood Glucose Monitoring System | NBW | 2017-09-15 | 92 |
| K141351 | SUPERCHECK PLUS BLOOD GLUCOSE MONITORING SYSTEM, SUPER CHECK PLUS MULTI BLOOD GLUCOSE MONITORING SYSTEM | NBW | 2015-05-19 | 362 |
| K133509 | EASY PLUS II BLOOD GLUCOSE MONITORING SYSTEM,EASY PLUS II MULTI BLOOD GLUCOSE MONITORING SYSTEM,SMARTEST PERSONA II BLOO | NBW | 2014-02-21 | 99 |
| K123559 | SOLUSMOBILE BLOOD GLUCOSE MANAGMENT SYSTEM | NBW | 2013-06-28 | 221 |
| K122525 | SMARTEST GLUCOWISE BLOOD GLUCOSE MONITORING SYSTEM, AND SMARTEST GLUCOSWISE MULTI BLOOD GLUCOSE MONITORING SYSTEM | NBW | 2013-05-02 | 255 |
| K100560 | EASY TALK BLOOD GLUCOSE MONITORING SYSTEM MODEL: 6277 | NBW | 2010-05-12 | 72 |
| K100701 | SMARTEST PERSONA BLOOD GLUCOSE TEST SYTEM MODEL: 6277 | NBW | 2010-04-08 | 27 |
| K093764 | SOLOV2 BLOOD GLUCOSE MONITORING SYSTEM | NBW | 2010-03-02 | 85 |
| K091815 | SUPERCHECK 1 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 6268 | NBW | 2009-11-16 | 151 |
Recalls
openFDA lists no recalls under a recalling firm named Biotest Medical Corp..
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.
- Biotest Diagnostics Corp. (5 510(k)s)
- Biotest Medizintechnik GmbH (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Biotest Medical Corp.?
FDA lists 10 510(k) clearances under the applicant name “Biotest Medical Corp.” (first 2009, latest 2017), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Biotest Medical Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biotest Medical Corp. is 96 days.
Which FDA product codes appear under Biotest Medical Corp.?
The most frequent FDA product codes under this applicant name are NBW (System, Test, Blood Glucose, Over The Counter, 10).
Next steps
- See all 10 Biotest Medical Corp. clearances with predicates and recalls
- Run predicate analysis for product code NBW, Biotest Medical Corp.'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.