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510(k) K780303

AUTO ISO-FILTER COLLECTION TUBE CAP by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code GJE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 1978
Date Received
February 23, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tray, Blood Collection
Device Class
Class II
Regulation Number
862.1675
Review Panel
CH
Submission Type

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  • K003461 — BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLE (February 1, 2001)
  • 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)
  • K000762 — MOXIFLOXACIN, 5 UG, BBL SENSI-DISC (April 25, 2000)
  • 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 GJE

  • K962596 — CUSTOMED BLOOD EXTRACTION KIT (September 27, 1996)
  • K925468 — JJ SKINNER CAREKITS(TM) BLOOD COLLECTION KIT (April 11, 1994)
  • K771489 — RTERIAL BLOOD SAMPLING KIT (August 22, 1977)
  • K771370 — ICROTAINEO BRAND TUBE (August 3, 1977)
  • K761177 — SODIUM CITRATE (January 10, 1977)
  • K760086 — TRAY, BLOOD SAMPLING (PULSATOR II) (July 16, 1976)