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510(k) K870369

Device
CALCIUM REAGENT-METHYL THYMOL BLUE METHOD
Applicant
TRACE SCIENTIFIC LTD.
510(k) number
K870369
Product code
CIA  
Decision
Substantially Equivalent (SESE)
Decision date
1987-08-19
Date received
1987-01-28
Regulation
862.1145
Classification name
Methylthymol Blue, Calcium
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
WILLIAM C RIDDLE
Address
10 Treforest Dr. Clayton, Vic 3168 AU

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code CIA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K863059CALCIOMETERJ. D. Assoc.1986-09-26
K822898DSL 1600Diagnostic Systems Laboratories, Inc.1982-12-09
K792396ELVI CALCIUMVolu Sol Medical Industries1979-12-06
K771468MULTISTAT III CALCIUM TESTInstrumentation Laboratory CO1977-09-12

Legacy Summary#

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FDA Review#

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