The following data is part of a premarket notification filed by Medica Corp. with the FDA for Easyra Cholesterol Reagent; Easyra Calcium Reagent Reagent.
| Device ID | K072249 |
| 510k Number | K072249 |
| Device Name: | EASYRA CHOLESTEROL REAGENT; EASYRA CALCIUM REAGENT REAGENT |
| Classification | Enzymatic Esterase--oxidase, Cholesterol |
| Applicant | MEDICA CORP. 163 CABOT STREET Beverly, MA 01915 |
| Contact | Fran White |
| Correspondent | Fran White MEDICA CORP. 163 CABOT STREET Beverly, MA 01915 |
| Product Code | CHH |
| CFR Regulation Number | 862.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-13 |
| Decision Date | 2008-02-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00386100002060 | K072249 | 000 |
| 00386100002008 | K072249 | 000 |