K800428 is an FDA 510(k) clearance for the TRYPTIC SOY BROTH W/CYSTEINE AND. This device is classified as a Culture Media, General Nutrient Broth (Class I - General Controls, product code JSC).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on March 19, 1980, 22 days after receiving the submission on February 26, 1980.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2350.
| 510(k) Number | K800428 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 26, 1980 |
| Decision Date | March 19, 1980 |
| Days to Decision | 22 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 |