K934146 is an FDA 510(k) clearance for the N-ASSAY TIA MICROALBUMIN. This device is classified as a Indicator Method, Protein Or Albumin (urinary, Non-quant.) (Class I — General Controls, product code JIR).
Submitted by Crestat Diagnostics, Inc. (Thousand Oaks, US). The FDA issued a Cleared decision on January 11, 1994, 140 days after receiving the submission on August 24, 1993.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1645.
| 510(k) Number | K934146 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 24, 1993 |
| Decision Date | January 11, 1994 |
| Days to Decision | 140 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 |