Name: Predicase
Price: 199 USD

K-number	K994006
Device name	AVOCET ACUSURE (FOR PATIENT SELF-TESTING) AND AVOCET ACUSURE PRO (FOR PROFESSIONAL USE)
Applicant	Avocet Medical, Inc.
Product code	GJS
Device class	Class II
Decision date	Feb 3, 2000
Decision	Substantially Equivalent
Regulation	864.7750

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Source

View the full FDA submission: accessdata.fda.gov

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AVOCET ACUSURE (FOR PATIENT SELF-TESTING) AND AVOCET ACUSURE PRO (FOR PROFESSIONAL USE)

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