The following data is part of a premarket notification filed by U. S. Diagnostics, Inc. with the FDA for Enzymatic Blood Glucose.
| Device ID | K862721 |
| 510k Number | K862721 |
| Device Name: | ENZYMATIC BLOOD GLUCOSE |
| Classification | Glucose Oxidase, Glucose |
| Applicant | U. S. DIAGNOSTICS, INC. P.O. BOX 4522 3443 MIGUELITO COURT San Luis Obispo, CA 93401 |
| Contact | Roy Speck |
| Correspondent | Roy Speck U. S. DIAGNOSTICS, INC. P.O. BOX 4522 3443 MIGUELITO COURT San Luis Obispo, CA 93401 |
| Product Code | CGA |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-17 |
| Decision Date | 1986-09-03 |