K862946 is an FDA 510(k) clearance for the OXOID SIGNAL BLOOD CULTURE SYSTEM. This device is classified as a Culture Media, Non-selective And Non-differential (Class I - General Controls, product code JSG).
Submitted by Oxoid U.S.A., Inc. (Hampshire Rg 24 Op, GB). The FDA issued a Cleared decision on November 5, 1986, 92 days after receiving the submission on August 5, 1986.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2300.
| 510(k) Number | K862946 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 05, 1986 |
| Decision Date | November 05, 1986 |
| Days to Decision | 92 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | JSG — Culture Media, Non-selective And Non-differential |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2300 |