ANGIOTENSIN CONVERTING ENZYME REA— 510(k) K942497

Name: FDA 510(k) clearance K942497
Creator: U.S. Food and Drug Administration
Published: 1994-11-15

Substantially Equivalent

American Laboratory Products Co., Ltd.

FDA 510(k) clearance K942497 for ANGIOTENSIN CONVERTING ENZYME REA, Substantially Equivalent on 1994-11-15. Applicant: American Laboratory Products Co., Ltd.. Device class: 2.

Clearance details

Applicant: American Laboratory Products Co., Ltd.
Product code: Code KQN
Device class: Class 2
Regulation: 21 CFR 862.1090
Advisory panel: Clinical Chemistry
Date received: 1994-05-17
Decision date: 1994-11-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Windham, NH, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KQN

view all

K041657 — THERMO ELECTRON ANGIOTENSIN CONVERTING ENZYME INFINITY (ACE) REAGENT2004-08-30
K913091 — BUEHLMANN LAB AS, ACE ANGIO CONV ENZYME KIN ASSAY1991-08-26
K854876 — ALDOSTERONE DIRECT RIA KIT1986-03-17
K854245 — SIGMA ANGIOTENSIN CONVERTING ENZYME 305-UV1986-01-22
K833933 — ACE COLOR TEST1984-03-23

More clearances from American Laboratory Products Co., Ltd.

view all

K012576 — CIC-C1Q EIA2002-01-29
K011415 — ALPCO MILENIA ANTI-TG EIA2001-05-30
K011201 — ALPCO MILENIA ANTI-TPO ELISA2001-05-24
K974701 — ORGENTEC ANTI-MPO (P-ANCA) ELISA1998-02-17
K974702 — ORGENTEC ANTI-PR3 (C-ANCA) ELISA1998-02-17

Data sourced from openFDA. This site is unofficial and independent of the FDA.