Name: Predicase
Price: 199 USD

K-number	K060621
Device name	SUSCEPTIBILITY TEST PLATE FOR ERTAPENEM 0.002-16UG/ML FOR GRAM NEGATIVE. SUSCEPTIBILITY TEST PLATE FOR ERTAPENEM 0.015-
Applicant	Tds Holdings, Inc.
Product code	JWY
Device class	Class II
Decision date	Apr 21, 2006
Decision	Substantially Equivalent
Regulation	866.1640

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View the full FDA submission: accessdata.fda.gov

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SUSCEPTIBILITY TEST PLATE FOR ERTAPENEM 0.002-16UG/ML FOR GRAM NEGATIVE. SUSCEPTIBILITY TEST PLATE FOR ERTAPENEM 0.015-

Everything you need for a 510(k) submission. Nothing you don't.