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510(k) K912897

SCEPTOR IDENTIFICATION SYSTEM by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code LQM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 1991
Date Received
July 1, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gram Negative Identification Panel
Device Class
Class I
Regulation Number
866.2660
Review Panel
MI
Submission Type

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  • 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 LQM

  • K923313 — ROCHE OXI/FERM II (April 5, 1993)
  • K925915 — VITEK RAPID CALL-GRAM NEGATIV IDENT CARD (March 23, 1993)
  • K911429 — VITEK GRAM NEGATIVE IDENTIFICATION CARD, MODIFIED (June 24, 1991)
  • K890057 — SENSITITRE AUTO ID PLATE AP80 (June 9, 1989)
  • K862642 — GRAM NEGATIVE FLUORESCENT IDENTIFICATION PANEL (September 11, 1986)
  • K851528 — PASCO GRAM NEGATIVE IDENTIFICATION SYSTEM (July 15, 1985)