CANTROL HDL CHOLESTEROL PRECIPI. REAG. AND TUBES

Ldl & Vldl Precipitation, Hdl

CANYON DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Canyon Diagnostics, Inc. with the FDA for Cantrol Hdl Cholesterol Precipi. Reag. And Tubes.

Pre-market Notification Details

Device IDK882488
510k NumberK882488
Device Name:CANTROL HDL CHOLESTEROL PRECIPI. REAG. AND TUBES
ClassificationLdl & Vldl Precipitation, Hdl
Applicant CANYON DIAGNOSTICS, INC. 4081 E. LA PALMA AVE., UNIT F Anaheim,  CA  92807
ContactFalkowski
CorrespondentFalkowski
CANYON DIAGNOSTICS, INC. 4081 E. LA PALMA AVE., UNIT F Anaheim,  CA  92807
Product CodeLBR  
CFR Regulation Number862.1475 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-06-16
Decision Date1988-08-15

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