Medical Device Manufacturer · US , Yarmouth , ME

Casco Standards - FDA 510(k) Cleared Devices

38 submissions · 38 cleared · Since 1984

38

Total

38

Cleared

0

Denied

FDA 510(k) Regulatory Record - Casco Standards Chemistry ✕

37 devices

1-12 of 37

Cleared Apr 24, 1998

DOCUMENT AMMONIA/ETHANOL/LACTATE CALIBRATOR, PN: M-109

Chemistry · 10d

Cleared Sep 13, 1996

DOCUMENT AMMONIA, ETHANOL, LACTATE CALIBRATOR

Chemistry · 70d

Cleared Jul 22, 1996

DOCUMENT CARDIAC ASSAYED CONTROL

Chemistry · 77d

Cleared Jul 22, 1996

DOCUMENT AMMONIA, ETHANOL, LACTATE ASSAYED CONTROL

Chemistry · 17d

Cleared Mar 22, 1996

DOCUMENT TDM ULTRA ASSAYED CONTROL

Chemistry · 66d

Cleared Dec 20, 1995

DOCUMENT TDM ULTRA UNASSAYED CONTROL

Chemistry · 37d

Cleared Apr 11, 1995

DOCUMENT SERUM MULTIANALYTE CALIBRATION VERIFICATION TEST SET

Chemistry · 67d

Cleared Jan 17, 1995

DOCUMENT(R) HDL CHOLESTEROL CALIBRATION VERIFICATION TEST SET

Chemistry · 57d

Cleared Dec 09, 1994

DOCUMENT(R) AMMONIA/ETHANOL AQUEOUS CONTROL

Chemistry · 38d

Cleared Nov 30, 1994

DOCUMENT R AMMONIA/ETHANOL CONTROL

Chemistry · 84d

Cleared Nov 15, 1994

DOCUMENT R AMMONIA / ETHANOL CALIBRATION VERIFICATION REST SET

Chemistry · 70d

Cleared Nov 15, 1994

DOCUMENTR AMMONIA/ETHANOLCALIBRATOR

Chemistry · 55d

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