510(k) K924365

VACUPLUS TUBES WITH BRICK RED STOPPERS by Starplex Scientific, Inc. — Product Code JKA

K924365 is an FDA 510(k) premarket notification submitted by Starplex Scientific, Inc. for the device "VACUPLUS TUBES WITH BRICK RED STOPPERS". The FDA issued a decision of Substantially Equivalent on December 28, 1992. The device falls under product code JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection), a Class II device regulated under 21 CFR 862.1675. Starplex Scientific, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 28, 1992
Date Received
August 28, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class
Class II
Regulation Number
862.1675
Review Panel
CH
Submission Type