The following data is part of a premarket notification filed by Hemagen Diagnostics, Inc. with the FDA for Raichem Bun Rate Reagent.
| Device ID | K012649 |
| 510k Number | K012649 |
| Device Name: | RAICHEM BUN RATE REAGENT |
| Classification | Urease And Glutamic Dehydrogenase, Urea Nitrogen |
| Applicant | HEMAGEN DIAGNOSTICS, INC. 9033 RED BRANCH RD. Columbia, MD 21045 |
| Contact | Jose A Montanez |
| Correspondent | Jose A Montanez HEMAGEN DIAGNOSTICS, INC. 9033 RED BRANCH RD. Columbia, MD 21045 |
| Product Code | CDQ |
| CFR Regulation Number | 862.1770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-13 |
| Decision Date | 2001-10-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817238011391 | K012649 | 000 |
| 00817238011193 | K012649 | 000 |
| 00817238010820 | K012649 | 000 |