The following data is part of a premarket notification filed by Alfa Wassermann Diagnostic Technologies, Inc. with the FDA for Ace Direct Totaliron-binding Capacity (tibc) Reagent, Ace Serum Iron Reagent, Ace Lipase Reagent.
| Device ID | K113438 |
| 510k Number | K113438 |
| Device Name: | ACE DIRECT TOTALIRON-BINDING CAPACITY (TIBC) REAGENT, ACE SERUM IRON REAGENT, ACE LIPASE REAGENT |
| Classification | Ferrozine (colorimetric) Iron Binding Capacity |
| 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 | JMO |
| Subsequent Product Code | CHI |
| Subsequent Product Code | JIY |
| CFR Regulation Number | 862.1415 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-21 |
| Decision Date | 2012-06-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857969006549 | K113438 | 000 |
| 00857969006495 | K113438 | 000 |
| 00857969006020 | K113438 | 000 |