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510(k) K821399

MACRO-VUE CARD TEST, NETILMICIN by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code LCE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 1982
Date Received
May 11, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Netilmicin (I-125)
Device Class
Class II
Regulation Number
862.3450
Review Panel
TX
Submission Type

Other clearances by Bd Becton Dickinson Vacutainer Systems Preanalytic

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  • 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 LCE

  • K833715 — EMIT NETILMICIN ASSAY (December 27, 1983)
  • K832088 — AMES TDA NETILMICIN TEST & SERUM (October 28, 1983)
  • K822941 — NETILMICIN FLUORESCENT IMMUNOASSAY (October 26, 1982)
  • K821698 — TDX NETILMICIN (June 22, 1982)
  • K820324 — EMIT AND NETILMICIN ASSAY (February 23, 1982)