K905829 is an FDA 510(k) clearance for the DETERMINER PL/DETERMINATION OF PHOSPHOLIPIDS. This device is classified as a Ammonium Molybdate And Ammonium Vanadate, Phospholipids (Class I - General Controls, product code CEL).
Submitted by Kamiya Biomedical Co. (Thousand Oaks, US). The FDA issued a Cleared decision on January 30, 1991, 30 days after receiving the submission on December 31, 1990.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1575.
| 510(k) Number | K905829 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 31, 1990 |
| Decision Date | January 30, 1991 |
| Days to Decision | 30 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CEL — Ammonium Molybdate And Ammonium Vanadate, Phospholipids |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1575 |