K963498 is an FDA 510(k) clearance for the FERR FLEX REAGENT CARTRIDGE. This device is classified as a Radioimmunoassay (two-site Solid Phase), Ferritin (Class II - Special Controls, product code JMG).
Submitted by Dade Chemistry Systems, Inc. (Newark, US). The FDA issued a Cleared decision on January 24, 1997, 143 days after receiving the submission on September 3, 1996.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 866.5340.
| 510(k) Number | K963498 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 03, 1996 |
| Decision Date | January 24, 1997 |
| Days to Decision | 143 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 |