The following data is part of a premarket notification filed by Derma Media Lab., Inc. with the FDA for Glucose Reagent.
| Device ID | K970664 |
| 510k Number | K970664 |
| Device Name: | GLUCOSE REAGENT |
| Classification | Hexokinase, Glucose |
| Applicant | DERMA MEDIA LAB., INC. 8531 WELLSFORD PL., SUITE E Santa Fe Springs, CA 90670 |
| Contact | Charles C Allain, Ph.d. |
| Correspondent | Charles C Allain, Ph.d. DERMA MEDIA LAB., INC. 8531 WELLSFORD PL., SUITE E Santa Fe Springs, CA 90670 |
| Product Code | CFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-21 |
| Decision Date | 1997-08-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851445007235 | K970664 | 000 |