510(k) K111335
K111335 is an FDA 510(k) premarket notification submitted by Tosoh Bioscience, Inc. for the device "ST AIA-PACK ACTH, AND ST AIA-PACK ACTH CALIBRATOR SET MODEL 025221 AND 025321". The FDA issued a decision of Substantially Equivalent on December 1, 2011. The device falls under product code CKG (Radioimmunoassay, Acth), a Class II device regulated under 21 CFR 862.1025. Tosoh Bioscience, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 1, 2011
- Date Received
- May 12, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radioimmunoassay, Acth
- Device Class
- Class II
- Regulation Number
- 862.1025
- Review Panel
- CH
- Submission Type