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510(k) K912897

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

K912897 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "SCEPTOR IDENTIFICATION SYSTEM". The FDA issued a decision of Substantially Equivalent on October 28, 1991. The device falls under product code LQM (Gram Negative Identification Panel), a Class I device regulated under 21 CFR 866.2660. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.

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

Other clearances by Bd Becton Dickinson Vacutainer Systems Preanalytic

  • K003062 — BACTEC MGIT 960 SIR KITS (June 6, 2001)
  • 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 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)

FDA data resources