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510(k) K823196

Device
SPECIAL CONTROL SERUM FOR HDL-CHOLES
Applicant
BOEHRINGER MANNHEIM CORP.
510(k) number
K823196
Product code
JJK  
Decision
Substantially Equivalent (SESE)
Decision date
1982-11-29
Date received
1982-10-26
Regulation
862.2720
Classification name
Oncometer, Plasma, For Clinical Use
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

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

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JJK  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K863099ABBOTT TESTPACK (TM) ACUTE HEP A CONTROL KITAbbott Laboratories1986-09-16
K802120HEPA-SHURE -LNuclear Medical Laboratories, Inc.1980-10-20
K760975WEIL ONCOMETER (IL 186)Instrumentation Laboratory CO1977-01-12

Legacy Summary#

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FDA Review#

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