The following data is part of a premarket notification filed by Genchem, Inc. with the FDA for Bun Reagent.
| Device ID | K040973 |
| 510k Number | K040973 |
| Device Name: | BUN REAGENT |
| Classification | Electrode, Ion Specific, Urea Nitrogen |
| 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 | CDS |
| CFR Regulation Number | 862.1770 [🔎] |
| 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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851445007075 | K040973 | 000 |
| 00851445007068 | K040973 | 000 |