The following data is part of a premarket notification filed by Alfa Wassermann Diagnostic Technologies, Inc. with the FDA for Ace Direct Total Iron-binding Capacity (tibc) Reagent, Ace Total Iron Reagent, Ace Ldh-l Reagent.
| Device ID | K131975 |
| 510k Number | K131975 |
| Device Name: | ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON REAGENT, ACE LDH-L REAGENT |
| Classification | Nad Reduction/nadh Oxidation, Lactate Dehydrogenase |
| 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 | CFJ |
| Subsequent Product Code | JIY |
| Subsequent Product Code | JMO |
| CFR Regulation Number | 862.1440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-28 |
| Decision Date | 2013-10-02 |
| Summary: | summary |