K801578 is an FDA 510(k) clearance for the COMBOSTAT - NO-BOIL KIT. This device is classified as a Radioassay, Vitamin B12 (Class II - Special Controls, product code CDD).
Submitted by Ria Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 23, 1980, 106 days after receiving the submission on July 9, 1980.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 862.1810.
| 510(k) Number | K801578 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 09, 1980 |
| Decision Date | October 23, 1980 |
| Days to Decision | 106 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | CDD — Radioassay, Vitamin B12 |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1810 |