510(k) K771874

J-VAC VACUUM TUBE by Jelco Laboratories — Product Code GIM

K771874 is an FDA 510(k) premarket notification submitted by Jelco Laboratories for the device "J-VAC VACUUM TUBE". The FDA issued a decision of Substantially Equivalent on December 2, 1977. The device falls under product code GIM (Tubes, Vacuum Sample, With Anticoagulant), a Class II device regulated under 21 CFR 862.1675. Jelco Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 2, 1977
Date Received
October 3, 1977
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