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510(k) K972132

SIGMA DIAGNOSTICS VALPROIC ACID FPIA REAGENT SET, SIGMA DIAGNOSTICS VALPROIC ACID FPIA CALIBRATORS by Sigma Diagnostics, Inc. — Product Code LEG

K972132 is an FDA 510(k) premarket notification submitted by Sigma Diagnostics, Inc. for the device "SIGMA DIAGNOSTICS VALPROIC ACID FPIA REAGENT SET, SIGMA DIAGNOSTICS VALPROIC ACID FPIA CALIBRATORS". The FDA issued a decision of Substantially Equivalent on July 30, 1997. The device falls under product code LEG (Enzyme Immunoassay, Valproic Acid), a Class II device regulated under 21 CFR 862.3645. Sigma Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 1997
Date Received
June 6, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Valproic Acid
Device Class
Class II
Regulation Number
862.3645
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 LEG

  • K090358 — ARCHITECT IVALPROIC ACID REAGENTS AND ARCHITECT IVALPROIC ACID CALIBRATORS, MODE (August 6, 2009)
  • K060690 — ONLINE VALPROIC ACID (August 8, 2006)
  • K042807 — ADVIA IMS VALPROIC ACID METHOD (February 8, 2005)
  • K042476 — VITROS CHEMISTRY PRODUCTS VALP REAGENT; VITRO CHEMISTRY PRODUCTS CALIBRATOR KIT (December 1, 2004)
  • K032049 — ROCHE ONLINE TDM VALPROIC ACID (August 22, 2003)
  • K031870 — SYNCHRON SYSTEMS VALPROIC ACID (V-PA) REAGENT (July 15, 2003)
  • K030405 — QMS / MULTIGENT VALPROIC ACID REAGENT, PART #396075 (April 28, 2003)
  • K011649 — RANDOX VALPROIC ACID (January 15, 2002)
  • K011947 — EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL (July 2, 2001)
  • K002551 — EMIT 2000 VALPROIC ACID ASSAY, EMIT 2000 VALPROIC ACID CALIBRATORS, MODEL 4G019U (October 11, 2000)

FDA data resources