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510(k) K913091

BUEHLMANN LAB AS, ACE ANGIO CONV ENZYME KIN ASSAY by American Laboratory Products Co., Ltd. — Product Code KQN

K913091 is an FDA 510(k) premarket notification submitted by American Laboratory Products Co., Ltd. for the device "BUEHLMANN LAB AS, ACE ANGIO CONV ENZYME KIN ASSAY". The FDA issued a decision of Substantially Equivalent on August 26, 1991. The device falls under product code KQN (Radioassay, Angiotensin Converting Enzyme), a Class II device regulated under 21 CFR 862.1090. American Laboratory Products Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 1991
Date Received
July 12, 1991
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 American Laboratory Products Co., Ltd.

  • K012576 — CIC-C1Q EIA (January 29, 2002)
  • K011415 — ALPCO MILENIA ANTI-TG EIA (May 30, 2001)
  • K011201 — ALPCO MILENIA ANTI-TPO ELISA (May 24, 2001)
  • K974701 — ORGENTEC ANTI-MPO (P-ANCA) ELISA (February 17, 1998)
  • K974702 — ORGENTEC ANTI-PR3 (C-ANCA) ELISA (February 17, 1998)
  • K972190 — THYROGLOBULIN ASSAY SYSTEM (July 14, 1997)
  • K970932 — ORGENTEC MICRO-ALBUMIN EIA ASSAY (April 8, 1997)
  • K962057 — ORGENTEC ANTI-RNP/SM ELISA (November 18, 1996)
  • K962062 — ORGENTEC ANTI-SM ELISA (November 18, 1996)
  • K962055 — ORGENTEC ANTI-SCL 70 ELISA (November 15, 1996)

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)
  • 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