K834357 is an FDA 510(k) clearance for the ANA TRANS TUBE & SWABS STERILE PACK. This device is classified as a Culture Media, Anaerobic Transport (Class I - General Controls, product code JSL).
Submitted by Anaerobe Systems (Mchenry, US). The FDA issued a Cleared decision on January 31, 1984, 49 days after receiving the submission on December 13, 1983.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2390.
| 510(k) Number | K834357 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 13, 1983 |
| Decision Date | January 31, 1984 |
| Days to Decision | 49 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | JSL — Culture Media, Anaerobic Transport |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2390 |