K-number	K900546
Device name	BARTELS NEISSERIA GONORRHOEAE DIRECT FLUORESCENT
Applicant	Baxter Healthcare Corp
Product code	GTH
Device class	Class II
Decision date	Jun 15, 1990
Decision	Substantially Equivalent
Regulation	866.3390

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View the full FDA submission: accessdata.fda.gov

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BARTELS NEISSERIA GONORRHOEAE DIRECT FLUORESCENT

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