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510(k) K792396

Device
ELVI CALCIUM
Applicant
VOLU SOL MEDICAL INDUSTRIES
510(k) number
K792396
Product code
CIA  
Decision
Substantially Equivalent (SESE)
Decision date
1979-12-06
Date received
1979-11-26
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#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

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
K870369CALCIUM REAGENT-METHYL THYMOL BLUE METHODTrace Scientific , Ltd.1987-08-19
K863059CALCIOMETERJ. D. Assoc.1986-09-26
K822898DSL 1600Diagnostic Systems Laboratories, Inc.1982-12-09
K771468MULTISTAT III CALCIUM TESTInstrumentation Laboratory CO1977-09-12

Legacy Summary#

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FDA Review#

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