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510(k) K854245

SIGMA ANGIOTENSIN CONVERTING ENZYME 305-UV by Sigma Diagnostics, Inc. — Product Code KQN

K854245 is an FDA 510(k) premarket notification submitted by Sigma Diagnostics, Inc. for the device "SIGMA ANGIOTENSIN CONVERTING ENZYME 305-UV". The FDA issued a decision of Substantially Equivalent on January 22, 1986. The device falls under product code KQN (Radioassay, Angiotensin Converting Enzyme), a Class II device regulated under 21 CFR 862.1090. Sigma Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 1986
Date Received
October 21, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioassay, Angiotensin Converting Enzyme
Device Class
Class II
Regulation Number
862.1090
Review Panel
CH
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)
  • 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)

Other clearances for product code KQN

  • K041657 — THERMO ELECTRON ANGIOTENSIN CONVERTING ENZYME INFINITY (ACE) REAGENT (August 30, 2004)
  • K942497 — ANGIOTENSIN CONVERTING ENZYME REA (November 15, 1994)
  • K913091 — BUEHLMANN LAB AS, ACE ANGIO CONV ENZYME KIN ASSAY (August 26, 1991)
  • K854876 — ALDOSTERONE DIRECT RIA KIT (March 17, 1986)
  • K833933 — ACE COLOR TEST (March 23, 1984)
  • K821011 — ACE ACTIVITY MICROVIAL TEST SET (May 3, 1982)
  • K791712 — ANGIOTENSIN CONVERTING ENZYME ASSAY SYS (September 19, 1979)

FDA data resources