Name: Predicase
Price: 199 USD

K-number	K010844
Device name	ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE KIT, 50 HOUR, PART NO. 80-8000-13K
Applicant	Astoria-Pacific, Inc.
Product code	NAK
Device class	Class II
Decision date	Sep 21, 2001
Decision	Substantially Equivalent
Regulation	862.1118

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Source

View the full FDA submission: accessdata.fda.gov

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ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE KIT, 50 HOUR, PART NO. 80-8000-13K

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