FDA 510(k) Regulatory Intelligence Search

Search devices, predicates, manufacturers and submission history used by regulatory affairs and medical device strategy teams.

175,218 clearances · 1976 to present · Updated monthly from FDA records

38 results for "Casco Standards"

1–24 of 38

Search insights Median review: 57d Cleared: 100% Top manufacturer: Casco Standards Lead specialty: Chemistry

Cleared Apr 24, 1998

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

DOCUMENT MOLECULAR PATHOLOGY CHLAMYDIA TRACHOMATIS CONTROL

DOCUMENT AMMONIA, ETHANOL, LACTATE CALIBRATOR

DOCUMENT AMMONIA, ETHANOL, LACTATE ASSAYED CONTROL

DOCUMENT CARDIAC ASSAYED CONTROL

DOCUMENT TDM ULTRA ASSAYED CONTROL

DOCUMENT TDM ULTRA UNASSAYED CONTROL

DOCUMENT SERUM MULTIANALYTE CALIBRATION VERIFICATION TEST SET

DOCUMENT(R) HDL CHOLESTEROL CALIBRATION VERIFICATION TEST SET

DOCUMENT(R) AMMONIA/ETHANOL AQUEOUS CONTROL

DOCUMENT R AMMONIA/ETHANOL CONTROL

DOCUMENTR AMMONIA/ETHANOLCALIBRATOR

DOCUMENT R AMMONIA / ETHANOL CALIBRATION VERIFICATION REST SET

DOCUMENT CHEM IV CALIBRATION VERIFICATION TEST SET

DOCULMENT(R) CHEM VI CALIBRATION VERIF TEST SET

DOCUMENT TOTAL AND DIRECT BILIRUBIN LINEARITY-MOD

DOCUMENT CHEM V CALIBRATION VERIFICATION TEST SET

DOCUMENT CHEM I CALIBRATION VERIFICATION TEST SET

DOCUMENT CHEM II CALIBRATION VERIFICATION TEST SET

DOCUMENT CHEM III CALIBRATION VERIFICATION TEST

DOCUMENT CK ISOENZYMES CONTROL

TDM I LINEARITY TEST SET

K913309 · DIF

Casco Standards

Chemistry · 50d