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510(k) K860453

ACE CONTROLS, NORMAL & ELEVATED, NO. A6040 & A7040 by Sigma Diagnostics, Inc. — Product Code JJX

K860453 is an FDA 510(k) premarket notification submitted by Sigma Diagnostics, Inc. for the device "ACE CONTROLS, NORMAL & ELEVATED, NO. A6040 & A7040". The FDA issued a decision of Substantially Equivalent on Feb 19, 1986. The device falls under product code JJX (Single (Specified) Analyte Controls (Assayed And Unassayed)), a Class I device regulated under 21 CFR 862.1660. Sigma Diagnostics, Inc. has 163 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Feb 19, 1986
Date Received
Feb 5, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
Device Class
Class I
Regulation Number
862.1660
Review Panel
CH
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)
  • 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 JJX

  • K170678 — Beta-CrossLaps CalCheck 5 (Apr 4, 2017)
  • K162173 — Elecsys CYFRA 21-1 CalCheck 5 (Jan 12, 2017)
  • K162514 — Multichem A1c (Oct 26, 2016)
  • K161874 — Audit MicroControls Linearity DROP LQ Blood Glucose (Aug 10, 2016)
  • K161526 — LIAISON CMV IgM Serum Control Set (Jun 30, 2016)
  • K161522 — LIAISON EBV IgM Serum Control Set (Jun 30, 2016)
  • K161082 — IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration… (May 17, 2016)
  • K152117 — Dropper hsCRP High Sensitivity CRP Control (Apr 21, 2016)
  • K151742 — Contour Next Control Solution (Sep 23, 2015)
  • K143687 — ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA… (Jul 17, 2015)

FDA data resources

Source: FDA 510(k) database entry for K860453. Report a data issue: hello@regdatalab.com.