K051714 is an FDA 510(k) clearance for the TOTAL BILE ACIDS ASSAY, MODEL DZ042A. This device is classified as a Radioimmunoassay, Cholyglycine, Bile Acids (Class II - Special Controls, product code KWW).
Submitted by Diazyme Laboratories (San Diego, US). The FDA issued a Cleared decision on December 7, 2005, 163 days after receiving the submission on June 27, 2005.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1177.
| 510(k) Number | K051714 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 27, 2005 |
| Decision Date | December 07, 2005 |
| Days to Decision | 163 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | KWW — Radioimmunoassay, Cholyglycine, Bile Acids |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1177 |