The following data is part of a premarket notification filed by Alfa Wassermann Diagnostic Technologies, Inc. with the FDA for Ace Ck Reagent,ace Bun/urea Reagent,ace Uric Acid Reagent,ace Creatinine Reagent.
| Device ID | K113389 |
| 510k Number | K113389 |
| Device Name: | ACE CK REAGENT,ACE BUN/UREA REAGENT,ACE URIC ACID REAGENT,ACE CREATININE REAGENT |
| Classification | Urease, Photometric, Urea Nitrogen |
| 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 | CDN |
| Subsequent Product Code | CGS |
| Subsequent Product Code | CGX |
| Subsequent Product Code | KNK |
| CFR Regulation Number | 862.1770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-16 |
| Decision Date | 2012-08-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857969006518 | K113389 | 000 |
| 00857969006464 | K113389 | 000 |