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510(k) K922468

ANGEL WING SETS -- MODIFIED by Mbo Laboratories, Inc. — Product Code GIM

K922468 is an FDA 510(k) premarket notification submitted by Mbo Laboratories, Inc. for the device "ANGEL WING SETS -- MODIFIED". The FDA issued a decision of Substantially Equivalent on July 10, 1992. The device falls under product code GIM (Tubes, Vacuum Sample, With Anticoagulant), a Class II device regulated under 21 CFR 862.1675. Mbo Laboratories, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 10, 1992
Date Received
May 13, 1992
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 Mbo Laboratories, Inc.

  • K920184 — ANGEL WING SAFETY BLOOD COLLECTION WITH TUBE HOLD. (February 18, 1992)
  • K912563 — ANGEL WING SAFETY BLOOD COLLECTION AND INFUSION SE (October 2, 1991)

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)
  • 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)

FDA data resources