The following data is part of a premarket notification filed by Genchem, Inc. with the FDA for Genchem Creatinine Reagent.
| Device ID | K040976 |
| 510k Number | K040976 |
| Device Name: | GENCHEM CREATININE REAGENT |
| Classification | Alkaline Picrate, Colorimetry, Creatinine |
| Applicant | GENCHEM, INC. 471 W. LAMBERT RD., SUITE 107 Brea, CA 92821 |
| Contact | C.c. Allain |
| Correspondent | C.c. Allain GENCHEM, INC. 471 W. LAMBERT RD., SUITE 107 Brea, CA 92821 |
| Product Code | CGX |
| CFR Regulation Number | 862.1225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-14 |
| Decision Date | 2004-12-27 |
| Summary: | summary |