K894169 is an FDA 510(k) clearance for the BIOTEL MICROALBUMINURIA (TM). This device is classified as a Indicator Method, Protein Or Albumin (urinary, Non-quant.) (Class I - General Controls, product code JIR).
Submitted by American Diagnostic Corp. (Oak Brook, US). The FDA issued a Cleared decision on September 18, 1989, 95 days after receiving the submission on June 15, 1989.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1645.
| 510(k) Number | K894169 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 15, 1989 |
| Decision Date | September 18, 1989 |
| Days to Decision | 95 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JIR — Indicator Method, Protein Or Albumin (urinary, Non-quant.) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1645 |