The following data is part of a premarket notification filed by Elan Pharma, Inc. with the FDA for Hichem Bun/urea Reagent Kit.
| Device ID | K960115 |
| 510k Number | K960115 |
| Device Name: | HICHEM BUN/UREA REAGENT KIT |
| Classification | Urease And Glutamic Dehydrogenase, Urea Nitrogen |
| Applicant | ELAN PHARMA, INC. 231 NORTH PUENTE ST. Brea, CA 92621 |
| Contact | Wynn Stocking |
| Correspondent | Wynn Stocking ELAN PHARMA, INC. 231 NORTH PUENTE ST. Brea, CA 92621 |
| Product Code | CDQ |
| CFR Regulation Number | 862.1770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-11 |
| Decision Date | 1996-03-29 |
| Summary: | summary |