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510(k) K843828

COBAS REAGENTS FOR TOBRAMYCIN & CALIBRA by Roche Diagnostic Systems, Inc. — Product Code LFW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 1985
Date Received
September 28, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fluorescence Polarization Immunoassay, Tobramycin
Device Class
Class II
Regulation Number
862.3900
Review Panel
TX
Submission Type

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  • K983556 — ABUSCREEN ONLINE BENZ 300 CALIBRATORS (December 15, 1998)
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Other clearances for product code LFW

  • K964670 — ROCHE COBAS-FP REAGENTS FOR TOBRAMYCIN (February 4, 1997)
  • K944371 — TOBRAMYCIN FPIA REAGENT SET AND CALIBRATOR (November 10, 1994)
  • K941614 — AXSYM TOBRAMYCIN (August 18, 1994)
  • K912143 — CEDIA(R) TOBRAMYCIN ASSAY (July 26, 1991)
  • K900707 — MODIFIED ACCUFLUOR TOBRAMYCIN REAGENT & CALIBRATOR (April 20, 1990)
  • K894531 — FPR TOBRAMYCIN KIT (September 1, 1989)
  • K872562 — INNOTRON INNOFLUOR TOBRAMYCIN REAGENT SET (August 17, 1987)
  • K854392 — TOBRAMYCIN KIT(FPIA)FLUORESCENCE POLARIZATION IMMU (December 5, 1985)
  • K841866 — INNOFLOUR TOBRAMYCIN (May 31, 1984)