510(k) K864208

VISION (TM) GGTP by Abbott Laboratories — Product Code JPZ

K864208 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "VISION (TM) GGTP". The FDA issued a decision of Substantially Equivalent on November 24, 1986. The device falls under product code JPZ (Colorimetric Method, Gamma-Glutamyl Transpeptidase), a Class I device regulated under 21 CFR 862.1360. Abbott Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 1986
Date Received
October 27, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Colorimetric Method, Gamma-Glutamyl Transpeptidase
Device Class
Class I
Regulation Number
862.1360
Review Panel
CH
Submission Type