Biotest Medical Corp.
Fairfax, VA, US
Biotest Medical Corp. appears in FDA device records in Fairfax, VA. FDA records list 10 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 10
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 10 510(k) clearances for Biotest Medical Corp. between 2009 and 2017. The busiest year on record is 2010, with 3. The most recent is 2017, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2009 | 1 |
| 2010 | 3 |
| 2013 | 2 |
| 2014 | 1 |
| 2015 | 1 |
| 2017 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K171822 | NuvoMed Wireless Blood Glucose Monitoring System (Model BGM-6/0352) | NBW | Substantially Equivalent | |
| K171785 | WowGoHealth Blood Glucose Monitoring System | NBW | Substantially Equivalent | |
| K141351 | SUPERCHECK PLUS BLOOD GLUCOSE MONITORING SYSTEM, SUPER CHECK PLUS MULTI BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | |
| K133509 | EASY PLUS II BLOOD GLUCOSE MONITORING SYSTEM,EASY PLUS II MULTI BLOOD GLUCOSE MONITORING SYSTEM,SMARTEST PERSONA II BLOO | NBW | Substantially Equivalent | |
| K123559 | SOLUSMOBILE BLOOD GLUCOSE MANAGMENT SYSTEM | NBW | Substantially Equivalent | |
| K122525 | SMARTEST GLUCOWISE BLOOD GLUCOSE MONITORING SYSTEM, AND SMARTEST GLUCOSWISE MULTI BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | |
| K100560 | EASY TALK BLOOD GLUCOSE MONITORING SYSTEM MODEL: 6277 | NBW | Substantially Equivalent | |
| K100701 | SMARTEST PERSONA BLOOD GLUCOSE TEST SYTEM MODEL: 6277 | NBW | Substantially Equivalent | |
| K093764 | SOLOV2 BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | |
| K091815 | SUPERCHECK 1 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 6268 | NBW | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Biotest Medical Corp. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
The self-serve claim needs an FDA establishment registration, FEI or owner-operator number on the company’s record, and we hold none for Biotest Medical Corp.. The only route for a company with no identifier on record is a person here: write to us, and one looks at the record and sends the same claim link by hand.
Data as of , FDA export datePage updated Source: openFDA, public domain