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510(k) K821266

BBL DIRECTIGEN MENINGITIS TEST KIT by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code GRP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 1, 1982
Date Received
May 3, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, All Types, H. Influenza
Device Class
Class II
Regulation Number
866.3300
Review Panel
MI
Submission Type

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  • 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 GRP

  • K884967 — BACTIGEN(R) H. INFLUENZAE TYPE B (February 7, 1989)
  • K854490 — IMMUNOSCAN DIRECT HEMOPHILUS INFLUENZAE TYPE B TES (December 27, 1985)
  • K831525 — H-FLU B ELISA TEST (September 29, 1983)
  • K823348 — H. INFLUENZA B ANTISERA FOR CIE (December 28, 1982)
  • K820192 — HAEMOPHILUS INFLUENZAE TYPE B ANTISERUM (March 11, 1982)