K-number	K921075
Device name	PHADEBACT MONOCLONAL GC TEST, MODIFICATION
Applicant	Karo Bio Diagnostics AB
Product code	LIC
Device class	Class II
Decision date	May 22, 1992
Decision	Substantially Equivalent
Regulation	866.3390

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View the full FDA submission: accessdata.fda.gov

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PHADEBACT MONOCLONAL GC TEST, MODIFICATION

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