K872955 is an FDA 510(k) clearance for the DELFIA(TM) FERRITIN KIT. This device is classified as a Radioimmunoassay (two-site Solid Phase), Ferritin (Class II - Special Controls, product code JMG).
Submitted by Lkb Instruments, Inc. (Gaithersburg, US). The FDA issued a Cleared decision on August 21, 1987, 23 days after receiving the submission on July 29, 1987.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.5340.
| 510(k) Number | K872955 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 29, 1987 |
| Decision Date | August 21, 1987 |
| Days to Decision | 23 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | JMG — Radioimmunoassay (two-site Solid Phase), Ferritin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5340 |