MSI-CAL 16

Calibrator For Hemoglobin And Hematocrit Measurement

MEDICAL SPECIALTIES, INC.

The following data is part of a premarket notification filed by Medical Specialties, Inc. with the FDA for Msi-cal 16.

Pre-market Notification Details

Device IDK883850
510k NumberK883850
Device Name:MSI-CAL 16
ClassificationCalibrator For Hemoglobin And Hematocrit Measurement
Applicant MEDICAL SPECIALTIES, INC. 3610 KENNEDY RD. South Plainfield,  NJ  07080
ContactRon Devita
CorrespondentRon Devita
MEDICAL SPECIALTIES, INC. 3610 KENNEDY RD. South Plainfield,  NJ  07080
Product CodeKRZ  
CFR Regulation Number864.8165 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-08-30
Decision Date1988-11-22

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.