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510(k) K780097

QUALITY CONTROL SYSTEM, SPECTRA by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code KSF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 1978
Date Received
January 19, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Quality Control For Blood Banking Reagents
Device Class
Class II
Regulation Number
864.9650
Review Panel
HE
Submission Type

Other clearances by Bd Becton Dickinson Vacutainer Systems Preanalytic

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  • K003553 — 0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE (March 21, 2001)
  • 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 KSF

  • K811713 — AVI-D CONTROL (October 23, 1981)
  • K810599 — DADE RH CONTROL REAGENT (March 31, 1981)
  • K801425 — RH CONTROL (July 14, 1980)
  • K800658 — RST-SERIES CONTROL (April 16, 1980)
  • K800310 — ORTHO ANTISERA CONTROL (March 5, 1980)
  • K800239 — RH-HR NEGATIVE CONTROL REAGENT (February 21, 1980)
  • K790249 — TEST CELLS (May 16, 1979)
  • K790025 — COUNTER CHECK, H001, H002, H003 (January 17, 1979)
  • K780665 — RECAP (June 6, 1978)
  • K771814 — REAGENT CONFIDENCE SERA (November 7, 1977)