The following data is part of a premarket notification filed by Microgenics Corp. with the FDA for Dri Hemoglobin A1c Assay And Calibrators.
| Device ID | K053411 |
| 510k Number | K053411 |
| Device Name: | DRI HEMOGLOBIN A1C ASSAY AND CALIBRATORS |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | MICROGENICS CORP. 46360 FREMONT BLVD. Fremont, CA 94538 |
| Contact | Tony C Lam |
| Correspondent | Tony C Lam MICROGENICS CORP. 46360 FREMONT BLVD. Fremont, CA 94538 |
| Product Code | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-07 |
| Decision Date | 2006-02-03 |
| Summary: | summary |