K111335 is an FDA 510(k) clearance for the ST AIA-PACK ACTH, AND ST AIA-PACK ACTH CALIBRATOR SET MODEL 025221 AND 025321. This device is classified as a Radioimmunoassay, Acth (Class II - Special Controls, product code CKG).
Submitted by Tosoh Bioscience, Inc. (South San Franciso, US). The FDA issued a Cleared decision on December 1, 2011, 203 days after receiving the submission on May 12, 2011.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1025.
| 510(k) Number | K111335 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 12, 2011 |
| Decision Date | December 01, 2011 |
| Days to Decision | 203 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CKG — Radioimmunoassay, Acth |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1025 |