K863164 is an FDA 510(k) clearance for the AGAR REDUCTION IN FORMULA FOR PDC 110 & 310 MEDIA. This device is classified as a Culture Media, Non-propagating Transport (Class I - General Controls, product code JSM).
Submitted by Precision Dynamics Corp. (San Fernando, US). The FDA issued a Cleared decision on August 27, 1986, 9 days after receiving the submission on August 18, 1986.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2390.
| 510(k) Number | K863164 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 18, 1986 |
| Decision Date | August 27, 1986 |
| Days to Decision | 9 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | JSM — Culture Media, Non-propagating Transport |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2390 |