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510(k) Data Aggregation

K Number

Device Name

DIASCREEN 50 URINE CHEMISTRY ANALYZER, MODEL # 1242-00; DIASCREEN REAGENT STRIP FOR URINALYSIS, CAT. # D11000

Manufacturer

HYPOGUARD USA, INC.

Date Cleared

2001-09-11

(162 days)

Product Code

JIL,CDM,CEN,JIN,JIO,JIR,JJB,JMT,KQO,KSL,LJX

Regulation Number

Type

Panel

Clinical Chemistry

Reference & Predicate Devices

N/A

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Device Name :

DIASCREEN 50 URINE CHEMISTRY ANALYZER, MODEL # 1242-00; DIASCREEN REAGENT STRIP FOR URINALYSIS, CAT.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

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