The following data is part of a premarket notification filed by Medical Analysis Systems, Inc. with the FDA for Reflab System Pack Liquid Fructosamine Reagent.
| Device ID | K920397 |
| 510k Number | K920397 |
| Device Name: | REFLAB SYSTEM PACK LIQUID FRUCTOSAMINE REAGENT |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | MEDICAL ANALYSIS SYSTEMS, INC. LINCOLN TECHNOLOGY PARK 542 FLYNN RD. Camarillo, CA 93012 |
| Contact | Donna L Anderson |
| Correspondent | Donna L Anderson MEDICAL ANALYSIS SYSTEMS, INC. LINCOLN TECHNOLOGY PARK 542 FLYNN RD. Camarillo, CA 93012 |
| Product Code | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-30 |
| Decision Date | 1992-08-04 |