Medical Device Manufacturer · IR , Antrim, N. Ireland

Randox Laboratories, Ltd. - FDA 510(k) Cleared Devices

116 submissions · 115 cleared · Since 1992

116

Total

115

Cleared

1

Denied

78 devices

76-78 of 78

Cleared Nov 16, 1992

AST (GOT) - ASPARTATE AMINOTRANSFERASE

Chemistry · 124d

Cleared Nov 16, 1992

ALT (GPT) - ALANINE AMINOTRANSFERASE

Chemistry · 124d

Cleared Oct 15, 1992

CK-NAC ACTIVATED KIT

Chemistry · 92d

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