Submission Details
| 510(k) Number | K850847 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 01, 1985 |
| Decision Date | March 20, 1985 |
| Days to Decision | 19 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
K850847 is an FDA 510(k) clearance for the THIOGLYCOLATE MEDIUM W/VITAMIN KL & HEMIN, a Culture Media, Non-selective And Non-differential (Class I — General Controls, product code JSG), submitted by Micro Media Laboratories (San Diego, US). The FDA issued a Cleared decision on March 20, 1985, 19 days after receiving the submission on March 1, 1985. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2300.
| 510(k) Number | K850847 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 01, 1985 |
| Decision Date | March 20, 1985 |
| Days to Decision | 19 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 |