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510(k) K832552

Device
SODIUM TEST KIT
Applicant
MALLINCKRODT CRITICAL CARE
510(k) number
K832552
Product code
CEI  
Decision
Substantially Equivalent (SESE)
Decision date
1983-09-20
Date received
1983-08-01
Regulation
862.1665
Classification name
Uranyl Acetate/zinc Acetate, Sodium
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code CEI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K043268SODIUM TEST KIT AND ELETROLYTE CAL 1 AND 2Randox Laboratories, Ltd.2005-02-15
K914039SODIUM REAGENT SETSterling Diagnostics, Inc.1991-10-31
K902572SODIUM REAGENT SETTech Intl. Co.1990-07-10

Legacy Summary#

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FDA Review#

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