Submission Details
| 510(k) Number | K874344 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 20, 1987 |
| Decision Date | November 06, 1987 |
| Days to Decision | 17 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
K874344 is an FDA 510(k) clearance for the QUAD PLATE (4 DIFFERENT MEDIA). This device is classified as a Culture Media, Selective And Differential (Class I — General Controls, product code JSI).
Submitted by Lakewood Biochemical Co., Inc. (Dallas, US). The FDA issued a Cleared decision on November 6, 1987, 17 days after receiving the submission on October 20, 1987.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2360.
| 510(k) Number | K874344 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 20, 1987 |
| Decision Date | November 06, 1987 |
| Days to Decision | 17 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | JSI — Culture Media, Selective And Differential |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 866.2360 |