The following data is part of a premarket notification filed by Alfa Wassermann Diagnostic Technologies, Llc with the FDA for Ace Hemoglobin A1c (hba1c) Reagent.
| Device ID | K170623 |
| 510k Number | K170623 |
| Device Name: | ACE Hemoglobin A1c (HbA1c) Reagent |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, LLC 4 Henderson Drive West Caldwell, NJ 07006 |
| Contact | Barbara Phillips |
| Correspondent | Barbara Phillips ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, LLC 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 | 2017-03-01 |
| Decision Date | 2018-02-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857969006617 | K170623 | 000 |