Name: Predicase
Price: 199 USD

K-number	K232317
Device name	UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent Strips
Applicant	Urit Medical Electronic Co., Ltd.
Product code	JIO
Device class	Class II
Decision date	Apr 26, 2024
Decision	Substantially Equivalent
Regulation	864.6550

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Source

View the full FDA submission: accessdata.fda.gov

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UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent Strips

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