Name: Predicase
Price: 199 USD

K-number	K212221
Device name	Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer
Applicant	Diazyme Laboratories, Inc.
Product code	DHA
Device class	Class II
Decision date	Dec 13, 2021
Decision	Substantially Equivalent
Regulation	862.1155

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Source

View the full FDA submission: accessdata.fda.gov

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Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer

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