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510(k) K934588

Device
CHLORIDE (MF) ASSAY
Applicant
DIAGNOSTIC CHEMICALS LTD.
510(k) number
K934588
Product code
CHG  
Decision
Substantially Equivalent (SESE)
Decision date
1994-02-18
Date received
1993-09-23
Regulation
862.1170
Classification name
Acid, Phosphoric-tungstic (spectrophotometric), Chloride
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
KAREN CALLBECK
Address
West Royalty Industrial Park, Charlottetown, P.E.I. CA C1E 2A6 C1E 2A6

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code CHG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K941807INTERSECT SYSTEMS' NON-MERCURIC CHLORIDE REAGENTIntersect Systems, Inc.1994-09-14
K903103SYNERMED CHLORIDE REAGENT KITSynermed, Inc.1990-08-09

Legacy Summary#

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FDA Review#

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