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510(k) K833724

Device
ENZYMATIC CO2
Applicant
AMERICAN MONITOR CORP.
510(k) number
K833724
Product code
CIL  
Decision
Substantially Equivalent (SESE)
Decision date
1983-12-29
Date received
1983-10-24
Regulation
862.1160
Classification name
Cresol Red Colorimetry, Carbon-dioxide
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

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
K922953SYSTEMATE CALCIUM TEST TECHNICON RA 1000Em Diagnostic Systems, Inc.1992-09-09
K895880PANCREATIC A-AMYLASE EPSBoehringer Mannheim Corp.1989-12-19
K800111CO2 CONTENTAmerican Monitor Corp.1980-02-13

Legacy Summary#

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FDA Review#

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