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510(k) K971221

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

K971221 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 2, 1997. The device falls under product code GIM (Tubes, Vacuum Sample, With Anticoagulant), 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 2, 1997
Date Received
April 2, 1997
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

Other clearances by Greiner America, Inc.

  • K971220 — GREINER VACUETTE BLOOD COLLECTION TUBE (June 4, 1997)
  • K971236 — GREINER VACUETTE BLOOD COLLECTION TUBE (May 12, 1997)
  • K971239 — GREINER VACUETTE BLOOD COLLECTION TUBE (May 12, 1997)
  • K960860 — GREINER VACUETTE BLOOD COLLECTION TUBE E/EDTA K3 (September 5, 1996)
  • K960857 — GREINER VACUETTE BLOOD COLLECTION TUBE W/LITHIUM HEPARIN & GEL SEPARATOR (August 30, 1996)
  • K960858 — GREINER VACUTTE BLOOD COLLECTION TUBE W/ CLOT ACTIVATOR & GEL SEPARATOR (August 30, 1996)

Other clearances for product code GIM

  • K240455 — BD Vacutainer® Citrate Blood Collection Tubes (October 31, 2024)
  • K230493 — BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blo (November 27, 2023)
  • K213670 — BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collecti (August 25, 2023)
  • K162723 — TransFix/EDTA Vacuum Blood Collection Tubes (June 22, 2017)
  • K080552 — CYTO-CHEX BCT (July 31, 2008)
  • K012152 — DS30 HCY BLOOD COLLECTION TUBES (September 18, 2001)
  • K971449 — VACUTAINER BRAND PLUS TUBE WITH EDTA ANTICOAGULANT(MULTIPLE) (June 17, 1997)
  • K951886 — LOK-ON NEEDLE DISPOSAL SYSTEM (June 30, 1995)
  • K945458 — VACUTAINER BRAND SAFETY-GARD PHLEBOTOMY SYSTEM (February 6, 1995)
  • K944814 — CORVAC PLASTIC BLOOD COLLECTION TUBE (December 19, 1994)

FDA data resources