Medical Device Manufacturer · US , Mchenry , IL

American Monitor Corp. - FDA 510(k) Cleared Devices

73 submissions · 73 cleared · Since 1977

73

Total

73

Cleared

0

Denied

FDA 510(k) Regulatory Record - American Monitor Corp. Chemistry ✕

69 devices

1-12 of 69

Cleared Jan 11, 1990

Chemistry · 90d

Cleared Jan 11, 1990

ASPARTATE AMINOTRANFERASE (AST)

Chemistry · 90d

Cleared Nov 13, 1989

ALANINE AMINOTRANSFERASE (ALT)

Chemistry · 31d

Cleared Oct 04, 1989

ACCESS CHEMISTRY ANALYZER

Chemistry · 27d

Cleared Aug 10, 1989

EXCEL (TM) CHEMISTRY ANALYZER

Chemistry · 107d

Cleared Jun 20, 1989

ENZYMATIC UREA NITROGEN REAGENT SET

Chemistry · 76d

Cleared Jun 19, 1989

CHOLESTEROL REAGENT SET

Chemistry · 46d

Cleared Jun 12, 1989

NEOCHROME(R) III GLUCOSE

Chemistry · 76d

Cleared Mar 24, 1989

GAMMA-GLUTAMYLTRANSFERASE

Chemistry · 60d

Cleared Feb 03, 1989

PHOTOMETRIC METHOD, IRON (NON-HEME) (75JIY)

Chemistry · 30d

Cleared Sep 13, 1988

DURAZYME(R) CPK

Chemistry · 27d

Cleared Aug 02, 1988

ENZYMATIC CO2 REAGENT SET

Chemistry · 46d

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