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510(k) K931523

Device
QUANTIMETRIX C-CLEAR(TM)
Applicant
QUANTIMETRIX CORP.
510(k) number
K931523
Product code
JMA  
Decision
Substantially Equivalent (SESE)
Decision date
1993-06-25
Date received
1993-03-26
Regulation
862.1095
Classification name
Acid, Ascorbic, 2,4-dinitrophenylhydrazine (spectrophotometric)
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
HIMAWAN SUTISNA
Address
4955 W. 145 St. Hawthorne CA US 90250 90250

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JMA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K830978HELENA BIOSTRIP AHelena Laboratories1983-05-13
K822709URITEST 9, INLAB REAGENT STRIPS URINALYLaprol Scientific, Inc.1983-01-28

Legacy Summary#

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FDA Review#

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