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510(k) K980525

Device
UBAS MANUAL METHOD AND UBAS AUTOMATED METHOD
Applicant
MARUKIN SHOYU CO., LTD.
510(k) number
K980525
Product code
KWX  
Decision
Substantially Equivalent (SESE)
Decision date
1998-04-15
Date received
1998-02-11
Regulation
862.1187
Classification name
Radioimmunoassay, Conjugated Sulfalithocholic (slcg) Acid, Bile Acids
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
GREG HOLLAND
Address
3722 Ave. Sausalito Irvine CA US 92606 92606

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KWX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K993941UBASMarukin Diagnostics2000-03-02

Legacy Summary#

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FDA Review#

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