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510(k) K791712

ANGIOTENSIN CONVERTING ENZYME ASSAY SYS by Ventrex Laboratories, Inc. — Product Code KQN

K791712 is an FDA 510(k) premarket notification submitted by Ventrex Laboratories, Inc. for the device "ANGIOTENSIN CONVERTING ENZYME ASSAY SYS". The FDA issued a decision of Substantially Equivalent on September 19, 1979. The device falls under product code KQN (Radioassay, Angiotensin Converting Enzyme), a Class II device regulated under 21 CFR 862.1090. Ventrex Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 1979
Date Received
July 31, 1979
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 Ventrex Laboratories, Inc.

  • K914554 — SPECIFIC IGE EIA-TURBO ASSAY (March 13, 1992)
  • K913833 — VENTREX ALLERGEN DISC (February 21, 1992)
  • K913434 — VENTREX COATED TUBE INTACT PTH (October 25, 1991)
  • K905612 — VENTREX COATED TUBE IGE RADIOIMMUNOASSAY (February 21, 1991)
  • K905636 — VENTREX COATED TUBE IGE ENZYME IMMUNOASSAY (February 7, 1991)
  • K905247 — SHBG IRMA KIT (January 17, 1991)
  • K904330 — TURBO-RAST SPECIFIC IGE ASSAY (December 7, 1990)
  • K903000 — TURBO-RAST SPECIFIC IGE ASSAY (July 31, 1990)
  • K897083 — VENTRESIGN STREP A TEST (January 22, 1990)
  • K895649 — COATED TUBE HIGH SENSITIVITY TSH 200 UIU/ML STAN. (January 18, 1990)

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)
  • 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)

FDA data resources