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510(k) K963537

SIGMA DIAGNOSTICS BUN REAGENT by Sigma Diagnostics, Inc. — Product Code LFP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 1996
Date Received
September 4, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Conductivity Rate, Urea Nitrogen
Device Class
Class II
Regulation Number
862.1770
Review Panel
CH
Submission Type

Other clearances by Sigma Diagnostics, Inc.

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  • K020109 — SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL (February 6, 2002)
  • K013549 — SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971 (December 26, 2001)
  • K013545 — SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221 (November 15, 2001)
  • K013544 — SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096 (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 LFP

  • K990039 — GAMBRO DQM 200 (January 27, 2000)
  • K992847 — HICHEM BUN REAGENT (October 14, 1999)
  • K933679 — SIGMA BUN REAGENT (December 17, 1993)
  • K873132 — BUN REAGENT KIT (October 23, 1987)
  • K812945 — LIQUILYME BUN REAGENT (November 6, 1981)