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510(k) K080552

CYTO-CHEX BCT by Streck — Product Code GIM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 2008
Date Received
February 28, 2008
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

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Other clearances for product code GIM

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  • K230493 — BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blo (November 27, 2023)
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  • K162723 — TransFix/EDTA Vacuum Blood Collection Tubes (June 22, 2017)
  • K012152 — DS30 HCY BLOOD COLLECTION TUBES (September 18, 2001)
  • K971449 — VACUTAINER BRAND PLUS TUBE WITH EDTA ANTICOAGULANT(MULTIPLE) (June 17, 1997)
  • K971221 — GREINER VACUETTE BLOOD COLLECTION TUBE (May 2, 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)