K070691 is an FDA 510(k) clearance for the BBL CHROMAGAR 0157. This device is classified as a Culture Media, Selective And Differential (Class I - General Controls, product code JSI).
Submitted by Becton, Dickinson & CO (Sparks, US). The FDA issued a Cleared decision on November 20, 2007, 252 days after receiving the submission on March 13, 2007.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2360.
| 510(k) Number | K070691 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 13, 2007 |
| Decision Date | November 20, 2007 |
| Days to Decision | 252 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | JSI — Culture Media, Selective And Differential |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2360 |