510(k) K781012

RIA TEST KIT SYS. DAMON KIQUISOL FREE by Damon Corp. — Product Code CEC

K781012 is an FDA 510(k) premarket notification submitted by Damon Corp. for the device "RIA TEST KIT SYS. DAMON KIQUISOL FREE". The FDA issued a decision of Substantially Equivalent on July 27, 1978. The device falls under product code CEC (Radioimmunoassay, Free Thyroxine), a Class II device regulated under 21 CFR 862.1695. Damon Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 1978
Date Received
June 16, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Free Thyroxine
Device Class
Class II
Regulation Number
862.1695
Review Panel
CH
Submission Type