The following data is part of a premarket notification filed by Tosoh Bioscience, Inc. with the FDA for St Aia-pack Acth, And St Aia-pack Acth Calibrator Set Model 025221 And 025321.
| Device ID | K111335 |
| 510k Number | K111335 |
| Device Name: | ST AIA-PACK ACTH, AND ST AIA-PACK ACTH CALIBRATOR SET MODEL 025221 AND 025321 |
| Classification | Radioimmunoassay, Acth |
| Applicant | Tosoh BioScience, Inc. 6000 SHORELINE COURT SUITE 101 South San Francisco, CA 94080 |
| Contact | Judith K Ogden |
| Correspondent | Judith K Ogden Tosoh BioScience, Inc. 6000 SHORELINE COURT SUITE 101 South San Francisco, CA 94080 |
| Product Code | CKG |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-12 |
| Decision Date | 2011-12-01 |
| Summary: | summary |