K823240 is an FDA 510(k) clearance for the CAP-RIA 16. This device is classified as a Counter (beta, Gamma) For Clinical Use (Class I - General Controls, product code JJJ).
Submitted by Capintec, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 3, 1982, 32 days after receiving the submission on November 1, 1982.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2320.
| 510(k) Number | K823240 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 01, 1982 |
| Decision Date | December 03, 1982 |
| Days to Decision | 32 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | - |
| Product Code | JJJ - Counter (beta, Gamma) For Clinical Use |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2320 |