The following data is part of a premarket notification filed by Microgenics Corp. with the FDA for Cedia(r) Folate (no Boil) Assay.
| Device ID | K946184 |
| 510k Number | K946184 |
| Device Name: | CEDIA(R) FOLATE (NO BOIL) ASSAY |
| Classification | Acid, Folic, Radioimmunoassay |
| Applicant | MICROGENICS CORP. 2380A BISSO LN. Concord, CA 94520 |
| Contact | Mary P Koning |
| Correspondent | Mary P Koning MICROGENICS CORP. 2380A BISSO LN. Concord, CA 94520 |
| Product Code | CGN |
| CFR Regulation Number | 862.1295 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-20 |
| Decision Date | 1995-01-17 |