510(k) K971236

GREINER VACUETTE BLOOD COLLECTION TUBE by Greiner America, Inc. — Product Code JKA

K971236 is an FDA 510(k) premarket notification submitted by Greiner America, Inc. for the device "GREINER VACUETTE BLOOD COLLECTION TUBE". The FDA issued a decision of Substantially Equivalent on May 12, 1997. The device falls under product code JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection), a Class II device regulated under 21 CFR 862.1675. Greiner America, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 12, 1997
Date Received
April 2, 1997
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