K120846 is an FDA 510(k) clearance for the TRANSPORT CULTURE MEDIUM DEVICE. This device is classified as a Device, Specimen Collection (Class I - General Controls, product code LIO).
Submitted by Puritan Medical Products, LLC (Guilford, US). The FDA issued a Cleared decision on June 8, 2012, 80 days after receiving the submission on March 20, 2012.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2900.
| 510(k) Number | K120846 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 20, 2012 |
| Decision Date | June 08, 2012 |
| Days to Decision | 80 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | LIO - Device, Specimen Collection |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2900 |