K874094 is an FDA 510(k) clearance for the 1205 BETAPLATE LIQUID SCINTILLATION COUNTER. This device is classified as a Counter (beta, Gamma) For Clinical Use (Class I - General Controls, product code JJJ).
Submitted by Lkb Instruments, Inc. (Gaithersburg, US). The FDA issued a Cleared decision on November 4, 1987, 35 days after receiving the submission on September 30, 1987.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2320.
| 510(k) Number | K874094 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 1987 |
| Decision Date | November 04, 1987 |
| Days to Decision | 35 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 |