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510(k) K895880

Device
PANCREATIC A-AMYLASE EPS
Applicant
BOEHRINGER MANNHEIM CORP.
510(k) number
K895880
Product code
CIL  
Decision
Substantially Equivalent (SESE)
Decision date
1989-12-19
Date received
1989-10-05
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#

Contact
CHERI EMMONS
Address
9115 Hague Rd. Indianapolis IN US 46250 46250

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
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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