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510(k) K922953

Device
SYSTEMATE CALCIUM TEST TECHNICON RA 1000
Applicant
EM DIAGNOSTIC SYSTEMS, INC.
510(k) number
K922953
Product code
CIL  
Decision
Substantially Equivalent (SESE)
Decision date
1992-09-09
Date received
1992-06-18
Regulation
862.1160
Classification name
Cresol Red Colorimetry, Carbon-dioxide
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
CAROL FAULKNER
Address
480 Democrat Rd. Gibbstown NJ US 08027 08027

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code CIL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K895880PANCREATIC A-AMYLASE EPSBoehringer Mannheim Corp.1989-12-19
K833724ENZYMATIC CO2American Monitor Corp.1983-12-29
K800111CO2 CONTENTAmerican Monitor Corp.1980-02-13

Legacy Summary#

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FDA Review#

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