FDA 510(k) Application Details - K952555

Device Classification Name Fluorescence Polarization Immunoassay, Diphenylhydantoin (Free)

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510(K) Number K952555
Device Name Fluorescence Polarization Immunoassay, Diphenylhydantoin (Free)
Applicant ROCHE DIAGNOSTIC SYSTEMS, INC.
BRANCHBURG TOWNSHIP
1080 U.S. HIGHWAY 202
SOMERVILLE, NJ US
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Contact RITA SMITH
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Regulation Number 862.3350

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Classification Product Code MOJ
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Date Received 06/02/1995
Decision Date 07/31/1995
Decision SE - Substantially Equivalent
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee TX - Clinical Toxicology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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