510(k) K910178

ACTH IRMA KIT MITSUBISHI YUKA by Science Regulatory Services Intl. — Product Code CKG

K910178 is an FDA 510(k) premarket notification submitted by Science Regulatory Services Intl. for the device "ACTH IRMA KIT MITSUBISHI YUKA". The FDA issued a decision of Substantially Equivalent on May 22, 1991. The device falls under product code CKG (Radioimmunoassay, Acth), a Class II device regulated under 21 CFR 862.1025. Science Regulatory Services Intl. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 1991
Date Received
January 15, 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