510(k) K771238

RID PLATES & INTENSI. FOR HUMAN IGE ETC by G.D. Searle And Co. — Product Code DGC

K771238 is an FDA 510(k) premarket notification submitted by G.D. Searle And Co. for the device "RID PLATES & INTENSI. FOR HUMAN IGE ETC". The FDA issued a decision of Substantially Equivalent on Jul 15, 1977. The device falls under product code DGC (Ige, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5510. G.D. Searle And Co. has 55 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Jul 15, 1977
Date Received
Jul 11, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Ige, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5510
Review Panel
IM
Submission Type
510(k)

Source: FDA 510(k) database entry for K771238. Report a data issue: hello@regdatalab.com.