K932950 is an FDA 510(k) clearance for the TINA-QUANT MICROALBUMIN. This device is classified as a Indicator Method, Protein Or Albumin (urinary, Non-quant.) (Class I - General Controls, product code JIR).
Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on February 10, 1995, 603 days after receiving the submission on June 17, 1993.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1645.
| 510(k) Number | K932950 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 17, 1993 |
| Decision Date | February 10, 1995 |
| Days to Decision | 603 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JIR — Indicator Method, Protein Or Albumin (urinary, Non-quant.) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1645 |