K881138 is an FDA 510(k) clearance for the CLINICAL ASSAYS GAMMACOAT [125I] FERRITIN IMMUNO.. This device is classified as a Radioimmunoassay (two-site Solid Phase), Ferritin (Class II - Special Controls, product code JMG).
Submitted by Baxter Healthcare Corp (Cambridge, US). The FDA issued a Cleared decision on April 21, 1988, 36 days after receiving the submission on March 16, 1988.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5340.
| 510(k) Number | K881138 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 16, 1988 |
| Decision Date | April 21, 1988 |
| Days to Decision | 36 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | JMG — Radioimmunoassay (two-site Solid Phase), Ferritin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5340 |