K833300 is an FDA 510(k) clearance for the SABOURAUD BHI AGAR. This device is classified as a Culture Media, General Nutrient Broth (Class I - General Controls, product code JSC).
Submitted by Acumedia Manufacturers, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 7, 1983, 46 days after receiving the submission on September 22, 1983.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2350.
| 510(k) Number | K833300 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 22, 1983 |
| Decision Date | November 07, 1983 |
| Days to Decision | 46 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | JSC — Culture Media, General Nutrient Broth |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2350 |