The following data is part of a premarket notification filed by Alfa Wassermann, Inc. with the FDA for S-test Creatinine (cre).
| Device ID | K080073 |
| 510k Number | K080073 |
| Device Name: | S-TEST CREATININE (CRE) |
| Classification | Enzymatic Method, Creatinine |
| Applicant | ALFA WASSERMANN, INC. 4 HENDERSON DR. West Caldwell, NJ 07006 |
| Contact | David Slavin |
| Correspondent | David Slavin ALFA WASSERMANN, INC. 4 HENDERSON DR. West Caldwell, NJ 07006 |
| Product Code | JFY |
| CFR Regulation Number | 862.1225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-11 |
| Decision Date | 2008-06-30 |
| Summary: | summary |