The following data is part of a premarket notification filed by Metrika, Inc. with the FDA for A1cnow For Home And Professional Use.
| Device ID | K033847 |
| 510k Number | K033847 |
| Device Name: | A1CNOW FOR HOME AND PROFESSIONAL USE |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | METRIKA, INC. 510 OAKMEAD PKWY. Sunnyvale, CA 94085 -4022 |
| Contact | Erika Ammirati |
| Correspondent | Erika Ammirati METRIKA, INC. 510 OAKMEAD PKWY. Sunnyvale, CA 94085 -4022 |
| Product Code | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-11 |
| Decision Date | 2003-12-23 |