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510(k) K020109

SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL by Sigma Diagnostics, Inc. — Product Code GGC

K020109 is an FDA 510(k) premarket notification submitted by Sigma Diagnostics, Inc. for the device "SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL". The FDA issued a decision of Substantially Equivalent on Feb 6, 2002. The device falls under product code GGC (Control, Plasma, Abnormal), a Class II device regulated under 21 CFR 864.5425. Sigma Diagnostics, Inc. has 163 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Feb 6, 2002
Date Received
Jan 11, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Control, Plasma, Abnormal
Device Class
Class II
Regulation Number
864.5425
Review Panel
HE
Submission Type
510(k) Exempt

Other clearances by Sigma Diagnostics, Inc.

  • K021162 — AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX… (Aug 30, 2002)
  • K013549 — SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971 (Dec 26, 2001)
  • K013545 — SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221 (Nov 15, 2001)
  • K013544 — SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096 (Nov 15, 2001)
  • K012410 — INFINITY HBA KIT, MODELS 537-A, 537-B (Oct 26, 2001)
  • K010652 — SIGMA DIAGNOSTICS SIGMA-CAL, MODEL S2936 (Mar 30, 2001)
  • K010158 — THROMBOMAX-HS WITH CALCIUM, MODEL T6540 (Mar 22, 2001)
  • K003267 — SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A (Mar 15, 2001)
  • K003328 — ACCUCLOT CONTROL I, MODEL A4089 (Mar 1, 2001)
  • K003329 — SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217 (Mar 1, 2001)

Other clearances for product code GGC

  • K102552 — HEMOSIL LA POSITIVE CONTROL (Apr 5, 2011)
  • K100103 — SPECIALTY ASSAYED CONTROL-2 (Dec 15, 2010)
  • K062306 — PLASMACON N, PLASMACON L-1, PLASMACON L-2 (Mar 16, 2007)
  • K061803 — STA - CONTROL LA 1+2 (Jul 28, 2006)
  • K032804 — CRYOCHECK WEAK LUPUS POSITIVE CONTROL (Nov 3, 2003)
  • K023312 — CONTROL PLASMA P (Nov 1, 2002)
  • K020878 — LYPHOCHEK HEMOSTASIS, MODELS 798, 799 (Apr 15, 2002)
  • K012422 — K-ASSAY D-DIMER CONTROLS (Aug 21, 2001)
  • K003329 — SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217 (Mar 1, 2001)
  • K993332 — GRADIPLASMA LA HIGH, GRADIPLASMA LA LOW MODELS LAHP-1, LAHP-05, LALP-1, LALP-05 (Feb 16, 2000)

FDA data resources

Source: FDA 510(k) database entry for K020109. Report a data issue: hello@regdatalab.com.