K-number	K851649
Device name	APO A-I IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN A1
Applicant	Photec Diagnostics, Inc.
Product code	DER
Device class	Class II
Decision date	Jun 5, 1985
Decision	Substantially Equivalent
Regulation	866.5580

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View the full FDA submission: accessdata.fda.gov

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APO A-I IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN A1

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