The following data is part of a premarket notification filed by Hemagen Diagnostics, Inc. with the FDA for Raichem Hdl Cholesterol Using Cantrol Hdl Precipitating Tubes On The Cobas Mira Anaylzer.
| Device ID | K023784 |
| 510k Number | K023784 |
| Device Name: | RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA ANAYLZER |
| Classification | Ldl & Vldl Precipitation, Hdl |
| 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 | LBR |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-11-12 |
| Decision Date | 2002-12-24 |