K780542 is an FDA 510(k) clearance for the ALFATEST. This device is classified as a Ldl & Vldl Precipitation, Hdl (Class I — General Controls, product code LBR).
Submitted by Panmed, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 19, 1978, 46 days after receiving the submission on April 3, 1978.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1475.
| 510(k) Number | K780542 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 03, 1978 |
| Decision Date | May 19, 1978 |
| Days to Decision | 46 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | LBR — Ldl & Vldl Precipitation, Hdl |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 862.1475 |