K946387 is an FDA 510(k) clearance for the CAPRA (CAPRAC-R) WIPETEST AND WELL COUNTER. This device is classified as a Counter (beta, Gamma) For Clinical Use (Class I - General Controls, product code JJJ).
Submitted by Capintec, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on March 30, 1995, 125 days after receiving the submission on November 25, 1994.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2320.
| 510(k) Number | K946387 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 25, 1994 |
| Decision Date | March 30, 1995 |
| Days to Decision | 125 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | JJJ — Counter (beta, Gamma) For Clinical Use |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2320 |