K880344 is an FDA 510(k) clearance for the IQ ALKALINE PHOSPHATASE. This device is classified as a Phenolphthalein Phosphate, Alkaline Phosphatase Or Isoenzymes (Class II - Special Controls, product code CJK).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on March 1, 1988, 35 days after receiving the submission on January 26, 1988.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1050.
| 510(k) Number | K880344 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 26, 1988 |
| Decision Date | March 01, 1988 |
| Days to Decision | 35 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CJK — Phenolphthalein Phosphate, Alkaline Phosphatase Or Isoenzymes |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1050 |