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510(k) K935058

FACTOR by Sigma Diagnostics, Inc. — Product Code GJT

K935058 is an FDA 510(k) premarket notification submitted by Sigma Diagnostics, Inc. for the device "FACTOR". The FDA issued a decision of Substantially Equivalent on Mar 7, 1994. The device falls under product code GJT (Plasma, Coagulation Factor Deficient), a Class II device regulated under 21 CFR 864.7290. Sigma Diagnostics, Inc. has 163 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Mar 7, 1994
Date Received
Oct 21, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Plasma, Coagulation Factor Deficient
Device Class
Class II
Regulation Number
864.7290
Review Panel
HE
Submission Type
510(k)

Other clearances by Sigma Diagnostics, Inc.

  • K021162 — AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX… (Aug 30, 2002)
  • K020109 — SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL (Feb 6, 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)

Other clearances for product code GJT

  • K222831 — CRYOcheck Factor VIII Deficient Plasma with VWF (Sep 13, 2023)
  • K180486 — HemosIL Factor XII Deficient Plasma (Mar 22, 2018)
  • K102851 — NOFACT VIII (Dec 19, 2011)
  • K102908 — NOFACT IX (Dec 19, 2011)
  • K110237 — HEMOSIL FACTOR VIII DEFICIENT PLASMA (Jul 8, 2011)
  • K050661 — HEMOSIL FACTOR II DEFICIENT PLASMA (May 2, 2005)
  • K043459 — HEMOSIL FACTOR XII DEFICIENT PLASMA (Feb 9, 2005)
  • K040362 — DIAPHARMA FACTOR X KIT (Jul 12, 2004)
  • K034007 — HEMOSIL FACTOR VIII DEFICIENT PLASMA (Feb 13, 2004)
  • K031829 — HEMOSIL FACTOR IX DEFICIENT PLASMA (Jul 31, 2003)

FDA data resources

Source: FDA 510(k) database entry for K935058. Report a data issue: hello@regdatalab.com.