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Registry EUDAMED FDA 510(k) incl. De Novo 143 FDA PMA GUDID

Country / market United States 143

Risk class Class I 43 Class IIa Class IIb Class III Class II (US) 99

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Class A Class B Class C Class D IVD General IVD Annex II List A IVD Annex II List B IVD for self-testing Active implantable (AIMDD) Unclassified (FDA) Not classified (FDA)

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143 devices foundsorted by relevance

Manufacturer: Diagnostic Chemicals, Ltd.× Clear all

DeviceDevice · Manufacturer · Authorizations Verified

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Creatinine-S Assay, Model 221-30, 221-50, 221-17

Diagnostic Chemicals, Ltd.,Canada(FDA applicant)

Active Regimes: 510(k) Registry: 510(k) Class:II
Lactate Denydro Genase Assay Kit

Diagnostic Chemicals, Ltd. (Usa),FDA registration: United States

Active Regimes: 510(k) Registry: 510(k) Class:II
Cholesterol Asssay Kit

Diagnostic Chemicals, Ltd. (Usa),FDA registration: United States

Active Regimes: 510(k) Registry: 510(k) Class:I

Showing 141-143 of 143

deviCERTS Global Medical Device Regulatory Database

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