The following data is part of a premarket notification filed by Seradyn Inc. with the FDA for Multigent Hemoglobin A1c (reagents), Hb A1c Calibrators And Hb A1c Controls.
| Device ID | K033674 |
| 510k Number | K033674 |
| Device Name: | MULTIGENT HEMOGLOBIN A1C (REAGENTS), HB A1C CALIBRATORS AND HB A1C CONTROLS |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | SERADYN INC. 7998 GEORGETOWN RD. SUITE 1000 Indianapolis, IN 46268 -5260 |
| Contact | Les Padilla |
| Correspondent | Les Padilla SERADYN INC. 7998 GEORGETOWN RD. SUITE 1000 Indianapolis, IN 46268 -5260 |
| Product Code | LCP |
| Subsequent Product Code | GGM |
| Subsequent Product Code | KRZ |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-24 |
| Decision Date | 2004-02-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00380740003623 | K033674 | 000 |
| 00380740003616 | K033674 | 000 |
| 00380740003609 | K033674 | 000 |