The following data is part of a premarket notification filed by Raichem with the FDA for Raichem Hdl-cholesterol Direct Reagent, Hdl-cholesterol Calibrator.
| Device ID | K982767 |
| 510k Number | K982767 |
| Device Name: | RAICHEM HDL-CHOLESTEROL DIRECT REAGENT, HDL-CHOLESTEROL CALIBRATOR |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | RAICHEM 8225 MERCURY COURT San Diego, CA 92129 |
| Contact | Melissa Saner |
| Correspondent | Melissa Saner RAICHEM 8225 MERCURY COURT San Diego, CA 92129 |
| Product Code | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-06 |
| Decision Date | 1998-09-21 |
| Summary: | summary |