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510(k) K021162

AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHED by Sigma Diagnostics, Inc. — Product Code JPA

K021162 is an FDA 510(k) premarket notification submitted by Sigma Diagnostics, Inc. for the device "AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHED". The FDA issued a decision of Substantially Equivalent on August 30, 2002. The device falls under product code JPA (System, Multipurpose For In Vitro Coagulation Studies), a Class II device regulated under 21 CFR 864.5425. Sigma Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 2002
Date Received
April 11, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Multipurpose For In Vitro Coagulation Studies
Device Class
Class II
Regulation Number
864.5425
Review Panel
HE
Submission Type

Other clearances by Sigma Diagnostics, Inc.

  • 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)
  • K003329 — SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217 (March 1, 2001)

Other clearances for product code JPA

  • K253658 — STA Satellite Max® (April 27, 2026)
  • K250965 — Automated Blood Coagulation Analyzer CN-Series (CN-6000) (June 2, 2025)
  • K251024 — TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge (April 30, 2025)
  • K243858 — TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge (January 15, 2025)
  • K232018 — Citrated: K, KH, RTH, FFH (March 29, 2024)
  • K233790 — ACL TOP 970 CL (December 29, 2023)
  • K221359 — ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein (September 29, 2023)
  • K212183 — STA R Max 3, STA Compact Max 3 (June 7, 2023)
  • K201440 — ROTEM sigma Thromboelastometry System (July 8, 2022)
  • K202101 — GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (A (December 29, 2021)

FDA data resources