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510(k) K972404

VACUTAINER BRAND SAFETY BLOOD COLLECTION ASSEMBLY(MULTIPLE) by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code KJA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 1997
Date Received
June 26, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Flask, Tissue Culture
Device Class
Class I
Regulation Number
864.2240
Review Panel
PA
Submission Type

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  • K002938 — B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/16 (November 29, 2000)
  • K001364 — BD DIRECTIGEN FLU A+B (June 28, 2000)
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  • K000829 — GATIFLOXACIN, 5 UG, BBL SENSI-DISC (April 13, 2000)
  • K993186 — SYNERCID, 15 UG, BBL SENSI-DISC (November 3, 1999)
  • K992734 — BECTON DICKINSON SYRINGE (October 1, 1999)
  • K992849 — QBC STAR CENTRIFUGAL HEMATOLOGY SYSTEM (September 23, 1999)

Other clearances for product code KJA

  • K933228 — KAPTON PEEL POUCH (March 30, 1994)
  • K885121 — CELL SCRAPER (December 28, 1988)
  • K873889 — TISSUE CULTURE TUBES (November 25, 1987)
  • K873890 — TISSUE CULTURE FLASKS (November 25, 1987)
  • K871324 — DU PONT STERICELL CELL CULTURE SYSTEM (April 14, 1987)
  • K870865 — TISSUE CULTURE BAG (March 30, 1987)
  • K864021 — TISSUE CULTURE FLASK (October 29, 1986)
  • K862152 — TISSUE CULTURE FLASK PL 732 PLASTIC ACCESSORY PROD (June 16, 1986)
  • K861253 — TISSUE CULTURE FLASK PL 732 PLASTIC (April 11, 1986)
  • K853441 — FETAL BOVINE SERUM IN TRANSFER CONTAINER (August 26, 1985)