CANTROL URINE DIPSTICK CONTROL TWO LEVELS

Urinalysis Controls (assayed And Unassayed)

CANYON DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Canyon Diagnostics, Inc. with the FDA for Cantrol Urine Dipstick Control Two Levels.

Pre-market Notification Details

Device IDK853603
510k NumberK853603
Device Name:CANTROL URINE DIPSTICK CONTROL TWO LEVELS
ClassificationUrinalysis Controls (assayed And Unassayed)
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 CodeJJW  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-08-28
Decision Date1985-10-08

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