The following data is part of a premarket notification filed by Hemagen Diagnostics, Inc. with the FDA for Raichem Phosporus Reagent.
| Device ID | K003012 |
| 510k Number | K003012 |
| Device Name: | RAICHEM PHOSPORUS REAGENT |
| Classification | Phosphomolybdate (colorimetric), Inorganic Phosphorus |
| 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 | CEO |
| CFR Regulation Number | 862.1580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-26 |
| Decision Date | 2000-10-25 |