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510(k) K810597

MACRO-VUE CARD TEST by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code KLB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 1981
Date Received
March 6, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Tobramycin
Device Class
Class II
Regulation Number
862.3900
Review Panel
TX
Submission Type

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  • K002938 — B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/16 (November 29, 2000)
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  • K993186 — SYNERCID, 15 UG, BBL SENSI-DISC (November 3, 1999)
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  • K992849 — QBC STAR CENTRIFUGAL HEMATOLOGY SYSTEM (September 23, 1999)

Other clearances for product code KLB

  • K060853 — ONLINE TDM TOBRAMYCIN (June 9, 2006)
  • K012312 — IMMULITE 2000 TOBRAMYCN, MODELS L2KTC2 (2002 TESTS), L2KTC6 (600 TESTS) (August 20, 2001)
  • K003341 — EMIT 2000 TOBRAMYCIN ASSAY EMIT 2000 TOBRAMYCIN CALIBRATORS (January 22, 2001)
  • K904304 — DUPONT DIMENSION(R) TOBRAMLLYCIN(TOBR) METHOD (October 26, 1990)
  • K903192 — IL TOBRAMYCIN ASSAY (August 22, 1990)
  • K893913 — TECHNICON RA SYSTEMS TOBRAMYCIN TEST METHOD (August 21, 1989)
  • K882294 — EMIT CONVENIENCE PACK: TOBRAMYCIN ASSAY (July 1, 1988)
  • K874223 — EMIT TOBRAMYCIN ASSAY (November 13, 1987)
  • K854184 — IN-VITRO TEST DETERMINATION OF TOBRAMYCIN (December 4, 1985)
  • K852671 — ACA TOBRAMY-CIN ANALYTICAL TEST PACK (July 22, 1985)