Submission Details
| 510(k) Number | K832588 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 02, 1983 |
| Decision Date | September 12, 1983 |
| Days to Decision | 41 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
K832588 is an FDA 510(k) clearance for the CIN AGAR, a Culture Media, Selective And Non-differential (Class I — General Controls, product code JSJ), submitted by Laboratory Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 12, 1983, 41 days after receiving the submission on August 2, 1983. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2360.
| 510(k) Number | K832588 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 02, 1983 |
| Decision Date | September 12, 1983 |
| Days to Decision | 41 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | JSJ — Culture Media, Selective And Non-differential |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 866.2360 |