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510(k) K041051

Device
RAICHEM BUN RATE REAGENT (LIQUID)
Applicant
Hemagen Diagnostics, Inc.
510(k) number
K041051
Product code
CDQ
Decision
Substantially Equivalent (SESE)
Decision date
2004-06-30
Date received
2004-04-19
Regulation
862.1770
Classification name
Urease And Glutamic Dehydrogenase, Urea Nitrogen
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
N

Applicant Contact#

Contact
JAMES J MILLER
Address
9033 Red Branch Rd. Columbia MD US 21045 21045

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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