The following data is part of a premarket notification filed by Medica Corp. with the FDA for Hdl Cholesterol Reagent, Model 10211.
| Device ID | K073497 |
| 510k Number | K073497 |
| Device Name: | HDL CHOLESTEROL REAGENT, MODEL 10211 |
| Classification | Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl |
| Applicant | MEDICA CORP. 5 OAK PARK DRIVE Bedford, MA 01730 |
| Contact | Photios Makris |
| Correspondent | Photios Makris MEDICA CORP. 5 OAK PARK DRIVE Bedford, MA 01730 |
| Product Code | LBS |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-13 |
| Decision Date | 2008-04-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00386100002077 | K073497 | 000 |
| 00386100001742 | K073497 | 000 |