Biotest Medical Corp.
FDA Regulatory Profile
Biotest Medical Corp. has 0 FDA recalls, 2 inspections, 10 510(k) clearances and 0 compliance actions on record.
- Latest inspection
- May 15, 2014 · VAI
- Latest 510(k)
- Sep 20, 2017
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 0 | Oct 23, 2026 | Not stated | Current |
|---|
| 510(k) clearances | 10 | Oct 4, 2026 | Not stated | Current |
|---|
| Inspections | 2 | Oct 25, 2026 | Not stated | Current |
|---|
| Compliance actions | 0 | Oct 23, 2026 | Not stated | Current |
|---|
Related names
| Name | Recalls | 510(k) | Inspections | Compliance | Most recent recall |
|---|
Bio-Test Medical
Same company group | 0 | 0 | 3 | 0 | — |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| May 15, 2014 | Taichung City, Taiwan | Devices | Voluntary Action Indicated (VAI) | 3004644399 |
| Nov 18, 2010 | Taichung City, Taiwan | Devices | Official Action Indicated (OAI) | 3004644399 |
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K171822 | NuvoMed Wireless Blood Glucose Monitoring System (Model BGM-6/0352) | Sep 20, 2017 |
| K171785 | WowGoHealth Blood Glucose Monitoring System | Sep 15, 2017 |
| K141351 | SUPERCHECK PLUS BLOOD GLUCOSE MONITORING SYSTEM, SUPER CHECK PLUS MULTI BLOOD GLUCOSE MONITORING… | May 19, 2015 |
| K133509 | EASY PLUS II BLOOD GLUCOSE MONITORING SYSTEM,EASY PLUS II MULTI BLOOD GLUCOSE MONITORING… | Feb 21, 2014 |
| K123559 | SOLUSMOBILE BLOOD GLUCOSE MANAGMENT SYSTEM | Jun 28, 2013 |
| K122525 | SMARTEST GLUCOWISE BLOOD GLUCOSE MONITORING SYSTEM, AND SMARTEST GLUCOSWISE MULTI BLOOD GLUCOSE… | May 2, 2013 |
| K100560 | EASY TALK BLOOD GLUCOSE MONITORING SYSTEM MODEL: 6277 | May 12, 2010 |
| K100701 | SMARTEST PERSONA BLOOD GLUCOSE TEST SYTEM MODEL: 6277 | Apr 8, 2010 |
| K093764 | SOLOV2 BLOOD GLUCOSE MONITORING SYSTEM | Mar 2, 2010 |
| K091815 | SUPERCHECK 1 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 6268 | Nov 16, 2009 |