K950393 is an FDA 510(k) clearance for the ACE(TM) CEDIA(R) FERRITIN ASSAY. This device is classified as a Radioimmunoassay (two-site Solid Phase), Ferritin (Class II - Special Controls, product code JMG).
Submitted by Schiapparelli Biosystems, Inc. (Columbia, US). The FDA issued a Cleared decision on May 16, 1995, 104 days after receiving the submission on February 1, 1995.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 866.5340.
| 510(k) Number | K950393 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 01, 1995 |
| Decision Date | May 16, 1995 |
| Days to Decision | 104 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JMG — Radioimmunoassay (two-site Solid Phase), Ferritin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5340 |