K894902 is an FDA 510(k) clearance for the SOURCERER. This device is classified as a Counter (beta, Gamma) For Clinical Use (Class I - General Controls, product code JJJ).
Submitted by Oakfield Instruments, Ltd. (Oxon Ox8 1ja England, GB). The FDA issued a Cleared decision on October 17, 1989, 77 days after receiving the submission on August 1, 1989.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.2320.
| 510(k) Number | K894902 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 01, 1989 |
| Decision Date | October 17, 1989 |
| Days to Decision | 77 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | JJJ — Counter (beta, Gamma) For Clinical Use |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2320 |