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510(k) K903103

Device
SYNERMED CHLORIDE REAGENT KIT
Applicant
SYNERMED, INC.
510(k) number
K903103
Product code
CHG  
Decision
Substantially Equivalent (SESE)
Decision date
1990-08-09
Date received
1990-07-13
Regulation
862.1170
Classification name
Acid, Phosphoric-tungstic (spectrophotometric), Chloride
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
MARCIA J ARENTZ
Address
1688 50th Ave., Montreal (Lachine), Quebec, Canada CA H8T 2V5 H8T 2V5

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
K934588CHLORIDE (MF) ASSAYDiagnostic Chemicals , Ltd.1994-02-18

Legacy Summary#

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FDA Review#

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