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 |