SLAVO CHOLESTEROL STAND. DIAGNOSTIC KIT

Calibrator, Secondary

SCLAVO, INC.

The following data is part of a premarket notification filed by Sclavo, Inc. with the FDA for Slavo Cholesterol Stand. Diagnostic Kit.

Pre-market Notification Details

Device IDK800770
510k NumberK800770
Device Name:SLAVO CHOLESTEROL STAND. DIAGNOSTIC KIT
ClassificationCalibrator, Secondary
Applicant SCLAVO, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJIT  
CFR Regulation Number862.1150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-04-07
Decision Date1980-04-21

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