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510(k) K915330

DIRECTIGEN MENINGITIS COMBO TEST KIT by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code GTJ

K915330 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "DIRECTIGEN MENINGITIS COMBO TEST KIT". The FDA issued a decision of Substantially Equivalent on March 23, 1992. The device falls under product code GTJ (Antisera, All Groups, N. Meningitidis), a Class II device regulated under 21 CFR 866.3390. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 1992
Date Received
November 26, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, All Groups, N. Meningitidis
Device Class
Class II
Regulation Number
866.3390
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 GTJ

  • K952791 — DIRECTIGEN MENINGITIS COMBO TEST (May 30, 1996)
  • K910210 — SLIDEX MENINGITE-KIT 5 (August 12, 1991)
  • K885004 — BACTIGEN(R) N. MENINGITIDIS (February 7, 1989)
  • K870089 — IMMUNOSCAN(TM) DIRECT NEISSERIA MENINGITIDIS KIT (March 17, 1987)
  • K854851 — WELLCOGEN N. MENINGITIDIS B/E. COLI K1 ZL24 (February 4, 1986)
  • K854852 — WELLCOGEN BACTERIAL ANTIGEN KIT (February 4, 1986)
  • K844999 — PHADEBACT CSF TEST (October 17, 1985)
  • K851691 — WILLCOGEN MENINGITIDIS KIT ZL25 (June 10, 1985)
  • K844762 — MENINGOCOCCUS GROUP B MONOCLONAL ANTIBODY ZM-51 (June 4, 1985)
  • K844407 — DIRECTIGEN NEISSENA MENNINGITIDIS GROUP B TEST (January 25, 1985)

FDA data resources