510(k) K772003

HUMAN REFERENCE SERUM C4 COMPLEMENT by G.D. Searle And Co. — Product Code DAK

K772003 is an FDA 510(k) premarket notification submitted by G.D. Searle And Co. for the device "HUMAN REFERENCE SERUM C4 COMPLEMENT". The FDA issued a decision of Substantially Equivalent on Nov 3, 1977. The device falls under product code DAK (Complement C1q, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5240. G.D. Searle And Co. has 55 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Nov 3, 1977
Date Received
Oct 21, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Complement C1q, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5240
Review Panel
IM
Submission Type
510(k)

Source: FDA 510(k) database entry for K772003. Report a data issue: hello@regdatalab.com.