510(k) K915727
K915727 is an FDA 510(k) premarket notification submitted by Mitsubishi Yuka America, Inc. for the device "ACTH IRMA KIT II MITSUBISHI YUKA". The FDA issued a decision of Substantially Equivalent on March 2, 1992. The device falls under product code CKG (Radioimmunoassay, Acth), a Class II device regulated under 21 CFR 862.1025. Mitsubishi Yuka America, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 2, 1992
- Date Received
- December 20, 1991
- 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