The following data is part of a premarket notification filed by Alfa Wassermann Diagnostic Technologies, Inc. with the FDA for S- Test Hemoglobin Alc (hba1c), Model Rc0023.
| Device ID | K091711 |
| 510k Number | K091711 |
| Device Name: | S- TEST HEMOGLOBIN ALC (HBA1C), MODEL RC0023 |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. 4 HENDERSON DRIVE West Caldwell, NJ 07006 |
| Contact | Hyman Katz |
| Correspondent | Hyman Katz ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. 4 HENDERSON DRIVE West Caldwell, NJ 07006 |
| Product Code | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-10 |
| Decision Date | 2009-12-11 |
| Summary: | summary |