The following data is part of a premarket notification filed by Hemagen Diagnostics, Inc. with the FDA for Raichem Ldl-cholesterol Direct Reagent.
| Device ID | K022772 |
| 510k Number | K022772 |
| Device Name: | RAICHEM LDL-CHOLESTEROL DIRECT REAGENT |
| Classification | System, Test, Low Density, Lipoprotein |
| 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 | MRR |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-08-21 |
| Decision Date | 2002-09-17 |