K810144 is an FDA 510(k) clearance for the ALK-PHOS BIOPAK GEL. This device is classified as a Electrophoretic Separation, Alkaline Phosphatase Isoenzymes (Class II - Special Controls, product code CIN).
Submitted by Bioware Products (Mchenry, US). The FDA issued a Cleared decision on February 2, 1981, 12 days after receiving the submission on January 21, 1981.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1050.
| 510(k) Number | K810144 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 21, 1981 |
| Decision Date | February 02, 1981 |
| Days to Decision | 12 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CIN — Electrophoretic Separation, Alkaline Phosphatase Isoenzymes |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1050 |