510(k) K772002

PLATES FOR HUMAN C4 COMPLEMENT by G.D. Searle And Co. — Product Code DBI

K772002 is an FDA 510(k) premarket notification submitted by G.D. Searle And Co. for the device "PLATES FOR HUMAN C4 COMPLEMENT". The FDA issued a decision of Substantially Equivalent on Nov 2, 1977. The device falls under product code DBI (Complement C4, 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 2, 1977
Date Received
Oct 21, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Complement C4, 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 K772002. Report a data issue: hello@regdatalab.com.