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510(k) K944371

TOBRAMYCIN FPIA REAGENT SET AND CALIBRATOR by Sigma Diagnostics, Inc. — Product Code LFW

K944371 is an FDA 510(k) premarket notification submitted by Sigma Diagnostics, Inc. for the device "TOBRAMYCIN FPIA REAGENT SET AND CALIBRATOR". The FDA issued a decision of Substantially Equivalent on November 10, 1994. The device falls under product code LFW (Fluorescence Polarization Immunoassay, Tobramycin), a Class II device regulated under 21 CFR 862.3900. Sigma Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 10, 1994
Date Received
September 7, 1994
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

Other clearances by Sigma Diagnostics, Inc.

  • K021162 — AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX D (August 30, 2002)
  • K020109 — SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL (February 6, 2002)
  • K013549 — SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971 (December 26, 2001)
  • K013544 — SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096 (November 15, 2001)
  • K013545 — SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221 (November 15, 2001)
  • K012410 — INFINITY HBA KIT, MODELS 537-A, 537-B (October 26, 2001)
  • K010652 — SIGMA DIAGNOSTICS SIGMA-CAL, MODEL S2936 (March 30, 2001)
  • K010158 — THROMBOMAX-HS WITH CALCIUM, MODEL T6540 (March 22, 2001)
  • K003267 — SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A (March 15, 2001)
  • K003328 — ACCUCLOT CONTROL I, MODEL A4089 (March 1, 2001)

Other clearances for product code LFW

  • K964670 — ROCHE COBAS-FP REAGENTS FOR TOBRAMYCIN (February 4, 1997)
  • 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)
  • K843828 — COBAS REAGENTS FOR TOBRAMYCIN & CALIBRA (February 1, 1985)
  • K841866 — INNOFLOUR TOBRAMYCIN (May 31, 1984)

FDA data resources