UNIFAST CALCIUM TEST

Cresolphthalein Complexone, Calcium

SCLAVO, INC.

The following data is part of a premarket notification filed by Sclavo, Inc. with the FDA for Unifast Calcium Test.

Pre-market Notification Details

Device IDK864661
510k NumberK864661
Device Name:UNIFAST CALCIUM TEST
ClassificationCresolphthalein Complexone, Calcium
Applicant SCLAVO, INC. 5 MANSARD COURT Wayne,  NJ  07470
ContactDebra Hofmeister
CorrespondentDebra Hofmeister
SCLAVO, INC. 5 MANSARD COURT Wayne,  NJ  07470
Product CodeCIC  
CFR Regulation Number862.1145 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-11-28
Decision Date1987-02-04

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