K863289 is an FDA 510(k) clearance for the CDC ANAEROBIC AGAR W/SHEEP BLOOD, KANA-&VANCOMYCIN. This device is classified as a Culture Media, Selective And Non-differential (Class I - General Controls, product code JSJ).
Submitted by Gibco Laboratories Life Technologies, Inc. (Madison, US). The FDA issued a Cleared decision on September 3, 1986, 9 days after receiving the submission on August 25, 1986.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2360.
| 510(k) Number | K863289 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 25, 1986 |
| Decision Date | September 03, 1986 |
| Days to Decision | 9 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | JSJ — Culture Media, Selective And Non-differential |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2360 |