Submission Details
| 510(k) Number | K880947 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 07, 1988 |
| Decision Date | April 01, 1988 |
| Days to Decision | 25 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
K880947 is an FDA 510(k) clearance for the NUTRIENT AGAR PLATE, SLANT TUBE AND BROTH TUBE, a Culture Media, Non-selective And Non-differential (Class I — General Controls, product code JSG), submitted by Lakewood Biochemical Co., Inc. (Dallas, US). The FDA issued a Cleared decision on April 1, 1988, 25 days after receiving the submission on March 7, 1988. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2300.
| 510(k) Number | K880947 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 07, 1988 |
| Decision Date | April 01, 1988 |
| Days to Decision | 25 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 |