Name: Predicase
Price: 199 USD

K-number	K182719
Device name	Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro
Applicant	Quidel Cardiovascular, Inc.
Product code	DKZ
Device class	Class II
Decision date	Jun 19, 2019
Decision	Substantially Equivalent
Regulation	862.3100

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Source

View the full FDA submission: accessdata.fda.gov

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Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro

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