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510(k) K854876

Device
ALDOSTERONE DIRECT RIA KIT
Applicant
BIOTECX LABORATORIES, INC.
510(k) number
K854876
Product code
KQN  
Decision
Substantially Equivalent (SESE)
Decision date
1986-03-17
Date received
1985-12-06
Regulation
862.1090
Classification name
Radioassay, Angiotensin Converting Enzyme
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
MOHAN MEHRA
Address
P.O. Box 1421 Friendswood TX US 77546 77546

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KQN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K041657THERMO ELECTRON ANGIOTENSIN CONVERTING ENZYME INFINITY (ACE) REAGENTThermo Electron Corporation2004-08-30
K942497ANGIOTENSIN CONVERTING ENZYME REAAmerican Laboratory Products Co., Ltd.1994-11-15
K913091BUEHLMANN LAB AS, ACE ANGIO CONV ENZYME KIN ASSAYAmerican Laboratory Products Co., Ltd.1991-08-26
K854245SIGMA ANGIOTENSIN CONVERTING ENZYME 305-UVSigma Diagnostics, Inc.1986-01-22
K833933ACE COLOR TESTHana Biologics, Inc.1984-03-23
K821011ACE ACTIVITY MICROVIAL TEST SETVentrex Laboratories, Inc.1982-05-03
K791712ANGIOTENSIN CONVERTING ENZYME ASSAY SYSVentrex Laboratories, Inc.1979-09-19

Legacy Summary#

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FDA Review#

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