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510(k) K920225

AUTOSCEPTOR IDENTIFICATION SYSTEM by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code LRH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 1992
Date Received
January 17, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument For Auto Reader Of Overnight Microorganism Identification System
Device Class
Class I
Regulation Number
866.2660
Review Panel
MI
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 LRH

  • K962609 — GRAM NEGATIVE IDENTIFICATION PLUS CARD (August 30, 1996)
  • K961042 — MICROSCAN RAPID GRAM-NEGATIVE INDENTIFICATION TYPE 3 PANEL (May 30, 1996)
  • K926248 — READER (May 17, 1994)