The following data is part of a premarket notification filed by Alfa Wassermann, Inc. with the FDA for Ace Hemoglobin A1c Reagent, Model Aci-21, Hemoglobin A1c Calibrators, Model S2-72, Hemoglobin A1c Controls, Model C2-72.
| Device ID | K063306 |
| 510k Number | K063306 |
| Device Name: | ACE HEMOGLOBIN A1C REAGENT, MODEL ACI-21, HEMOGLOBIN A1C CALIBRATORS, MODEL S2-72, HEMOGLOBIN A1C CONTROLS, MODEL C2-72 |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | ALFA WASSERMANN, INC. 4 HENDERSON DR. West Caldwell, NJ 07006 |
| Contact | Murray Rosenthal, Phd |
| Correspondent | Murray Rosenthal, Phd ALFA WASSERMANN, INC. 4 HENDERSON DR. West Caldwell, NJ 07006 |
| Product Code | LCP |
| Subsequent Product Code | JIS |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-01 |
| Decision Date | 2007-04-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857969006600 | K063306 | 000 |