Name: Predicase
Price: 199 USD

K-number	K163015
Device name	Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPak
Applicant	Bio-Rad Laboratories
Product code	JJY
Device class	Class I
Decision date	Jan 10, 2017
Decision	Substantially Equivalent
Regulation	862.1660

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Source

View the full FDA submission: accessdata.fda.gov

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Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPak

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