The following data is part of a premarket notification filed by Hemagen Diagnostics, Inc. with the FDA for Raichem Creatinine Urine Standard.
| Device ID | K011126 |
| 510k Number | K011126 |
| Device Name: | RAICHEM CREATININE URINE STANDARD |
| Classification | Calibrator, Secondary |
| 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 | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-13 |
| Decision Date | 2001-05-02 |