K801076 is an FDA 510(k) clearance for the WAKO PHOSPHOLIPIDS TEST. This device is classified as a Ammonium Molybdate And Ammonium Vanadate, Phospholipids (Class I — General Controls, product code CEL).
Submitted by Wako Pure Chemical Industries, Ltd. (Mchenry, US). The FDA issued a Cleared decision on June 30, 1980, 54 days after receiving the submission on May 7, 1980.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1575.
| 510(k) Number | K801076 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 07, 1980 |
| Decision Date | June 30, 1980 |
| Days to Decision | 54 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 |