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510(k) K914039

Device
SODIUM REAGENT SET
Applicant
STERLING DIAGNOSTICS, INC.
510(k) number
K914039
Product code
CEI  
Decision
Substantially Equivalent (SESE)
Decision date
1991-10-31
Date received
1991-09-10
Regulation
862.1665
Classification name
Uranyl Acetate/zinc Acetate, Sodium
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
DAVID L CALLENDER
Address
6226 Product Dr. Sterling Heights MI US 48312 48312

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
K902572SODIUM REAGENT SETTech Intl. Co.1990-07-10
K832552SODIUM TEST KITMallinckrodt Critical Care1983-09-20

Legacy Summary#

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FDA Review#

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