The following data is part of a premarket notification filed by Metrika, Inc. with the FDA for Drx Hba1c - For Prescription Home Use.
| Device ID | K000885 |
| 510k Number | K000885 |
| Device Name: | DRX HBA1C - FOR PRESCRIPTION HOME USE |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | METRIKA, INC. 510 OAKMEAD PKWY. Sunnyvale, CA 94085 -4022 |
| Contact | Joel M Blatt |
| Correspondent | Joel M Blatt METRIKA, INC. 510 OAKMEAD PKWY. Sunnyvale, CA 94085 -4022 |
| Product Code | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-20 |
| Decision Date | 2000-09-26 |