The following data is part of a premarket notification filed by Biotest Medical Corp. with the FDA for Supercheck 1 Blood Glucose Monitoring System, Model 6268.
| Device ID | K091815 |
| 510k Number | K091815 |
| Device Name: | SUPERCHECK 1 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 6268 |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | Biotest Medical Corp. 2995 STEVEN MARTIN DR. Fairfax, VA 22031 |
| Contact | Diane Mandell Horwitz |
| Correspondent | Diane Mandell Horwitz Biotest Medical Corp. 2995 STEVEN MARTIN DR. Fairfax, VA 22031 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-18 |
| Decision Date | 2009-11-16 |
| Summary: | summary |