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510(k) K863099

Device
ABBOTT TESTPACK (TM) ACUTE HEP A CONTROL KIT
Applicant
ABBOTT LABORATORIES
510(k) number
K863099
Product code
JJK  
Decision
Substantially Equivalent (SESE)
Decision date
1986-09-16
Date received
1986-08-13
Regulation
862.2720
Classification name
Oncometer, Plasma, For Clinical Use
Medical specialty
Clinical Chemistry
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
MATT KLAMRZYNSKI
Address
One Abbott Park Rd. Abbott Park IL US 60064 60064

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
K823196SPECIAL CONTROL SERUM FOR HDL-CHOLESBoehringer Mannheim Corp.1982-11-29
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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