The following data is part of a premarket notification filed by Medica Corp. with the FDA for Easyra Amylase, Bun, Glu-h, Trig, Uric Reagent.
| Device ID | K080823 |
| 510k Number | K080823 |
| Device Name: | EASYRA AMYLASE, BUN, GLU-H, TRIG, URIC REAGENT |
| Classification | Catalytic Methods, Amylase |
| 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 | JFJ |
| Subsequent Product Code | CDQ |
| Subsequent Product Code | CDT |
| Subsequent Product Code | CFR |
| Subsequent Product Code | KNK |
| CFR Regulation Number | 862.1070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-24 |
| Decision Date | 2008-11-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00386100002138 | K080823 | 000 |
| 00386100002121 | K080823 | 000 |
| 00386100002046 | K080823 | 000 |
| 00386100001988 | K080823 | 000 |