The following data is part of a premarket notification filed by Alfa Wassermann Diagnostic Technologies, Inc. with the FDA for Ace Hemoglobin Alc(hbalc) Reagent, Ace Cedia T Uptake Reagent, Ace T4 Reagent, Ace Ferritin Reagent.
| Device ID | K113437 |
| 510k Number | K113437 |
| Device Name: | ACE HEMOGLOBIN ALC(HBALC) REAGENT, ACE CEDIA T UPTAKE REAGENT, ACE T4 REAGENT, ACE FERRITIN REAGENT |
| 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 |
| Subsequent Product Code | DBF |
| Subsequent Product Code | KHQ |
| Subsequent Product Code | KLI |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-21 |
| Decision Date | 2012-08-06 |
| Summary: | summary |