Submission Details
| 510(k) Number | K873411 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 24, 1987 |
| Decision Date | October 06, 1987 |
| Days to Decision | 43 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
K873411 is an FDA 510(k) clearance for the SIMMONS CITRATE MEDIUM SLANT, PRODUCT #T3084, a Culture Media, Non-selective And Differential (Class I — General Controls, product code JSH), submitted by Lakewood Biochemical Co., Inc. (Dallas, US). The FDA issued a Cleared decision on October 6, 1987, 43 days after receiving the submission on August 24, 1987. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2320.
| 510(k) Number | K873411 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 24, 1987 |
| Decision Date | October 06, 1987 |
| Days to Decision | 43 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | JSH — Culture Media, Non-selective And Differential |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 866.2320 |