510(k) K874270

REVISED LABELING FOR LSD TEST KIT by Roche Diagnostic Systems, Inc. — Product Code DLB

K874270 is an FDA 510(k) premarket notification submitted by Roche Diagnostic Systems, Inc. for the device "REVISED LABELING FOR LSD TEST KIT". The FDA issued a decision of Substantially Equivalent on November 13, 1987. The device falls under product code DLB (Radioimmunoassay, Lsd (125-I)), a Class II device regulated under 21 CFR 862.3580. Roche Diagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 1987
Date Received
October 20, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Lsd (125-I)
Device Class
Class II
Regulation Number
862.3580
Review Panel
TX
Submission Type