K951222 is an FDA 510(k) clearance for the TOTAL PROTEIN (URINE). This device is classified as a Indicator Method, Protein Or Albumin (urinary, Non-quant.) (Class I - General Controls, product code JIR).
Submitted by Randox Laboratories, Ltd. (Crumlin, IE). The FDA issued a Cleared decision on April 24, 1996, 401 days after receiving the submission on March 20, 1995.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1645.
| 510(k) Number | K951222 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 20, 1995 |
| Decision Date | April 24, 1996 |
| Days to Decision | 401 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | JIR — Indicator Method, Protein Or Albumin (urinary, Non-quant.) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1645 |