510(k) K914901

VACUTAINER KIT by Abbott Laboratories — Product Code GIM

K914901 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "VACUTAINER KIT". The FDA issued a decision of Substantially Equivalent on January 8, 1992. The device falls under product code GIM (Tubes, Vacuum Sample, With Anticoagulant), a Class II device regulated under 21 CFR 862.1675. Abbott Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 1992
Date Received
November 1, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Vacuum Sample, With Anticoagulant
Device Class
Class II
Regulation Number
862.1675
Review Panel
CH
Submission Type