MSI-HB HEMOGLOBIN CONTROL

Mixture, Hematology Quality Control

MEDICAL SPECIALTIES, INC.

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

Pre-market Notification Details

Device IDK853776
510k NumberK853776
Device Name:MSI-HB HEMOGLOBIN CONTROL
ClassificationMixture, Hematology Quality Control
Applicant MEDICAL SPECIALTIES, INC. 3610 KENNEDY RD. South Plainfield,  NJ  07080
ContactRichard Cocco
CorrespondentRichard Cocco
MEDICAL SPECIALTIES, INC. 3610 KENNEDY RD. South Plainfield,  NJ  07080
Product CodeJPK  
CFR Regulation Number864.8625 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-09-10
Decision Date1985-09-19

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00884883005860 K853776 000
00884883005853 K853776 000
00884883005846 K853776 000
00884883005839 K853776 000

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