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510(k) K041657

THERMO ELECTRON ANGIOTENSIN CONVERTING ENZYME INFINITY (ACE) REAGENT by Thermo Electron Corporation — Product Code KQN

K041657 is an FDA 510(k) premarket notification submitted by Thermo Electron Corporation for the device "THERMO ELECTRON ANGIOTENSIN CONVERTING ENZYME INFINITY (ACE) REAGENT". The FDA issued a decision of Substantially Equivalent on August 30, 2004. The device falls under product code KQN (Radioassay, Angiotensin Converting Enzyme), a Class II device regulated under 21 CFR 862.1090. Thermo Electron Corporation has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 2004
Date Received
June 18, 2004
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 Thermo Electron Corporation

  • K042767 — DATAPRO CLINICAL CHELISTRY ANALYZER (April 27, 2005)

Other clearances for product code KQN

  • 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)
  • K854245 — SIGMA ANGIOTENSIN CONVERTING ENZYME 305-UV (January 22, 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