K822150 is an FDA 510(k) clearance for the AMNISTAT-FLM. This device is classified as a Chromatographic Separation, Lecithin/sphingomyelin Ratio (Class II - Special Controls, product code JHG).
Submitted by Hana Biologics, Inc. (Walker, US). The FDA issued a Cleared decision on October 21, 1982, 91 days after receiving the submission on July 22, 1982.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 862.1455.
| 510(k) Number | K822150 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 22, 1982 |
| Decision Date | October 21, 1982 |
| Days to Decision | 91 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | JHG — Chromatographic Separation, Lecithin/sphingomyelin Ratio |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1455 |