K954977 is an FDA 510(k) clearance for the URINE REAGENTS STRIPS-8 PARAMETERS (MODIFICATION). This device is classified as a Refractometer For Clinical Use (Class I - General Controls, product code JRE).
Submitted by Teco Diagnostics (Placentia, US). The FDA issued a Cleared decision on March 11, 1996, 147 days after receiving the submission on October 16, 1995.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2800.
| 510(k) Number | K954977 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 16, 1995 |
| Decision Date | March 11, 1996 |
| Days to Decision | 147 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | JRE — Refractometer For Clinical Use |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2800 |