Home / 510(k) Clearances / K010158

510(k) K010158

THROMBOMAX-HS WITH CALCIUM, MODEL T6540 by Sigma Diagnostics, Inc. — Product Code GGO

K010158 is an FDA 510(k) premarket notification submitted by Sigma Diagnostics, Inc. for the device "THROMBOMAX-HS WITH CALCIUM, MODEL T6540". The FDA issued a decision of Substantially Equivalent on March 22, 2001. The device falls under product code GGO (Reagent, Thromboplastin And Control), a Class II device regulated under 21 CFR 864.7925. Sigma Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 2001
Date Received
January 17, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reagent, Thromboplastin And Control
Device Class
Class II
Regulation Number
864.7925
Review Panel
HE
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)
  • 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)
  • K003267 — SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A (March 15, 2001)
  • K003328 — ACCUCLOT CONTROL I, MODEL A4089 (March 1, 2001)
  • K003329 — SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217 (March 1, 2001)

FDA data resources