QUANTIMETRIC 2 TEST KIT

Slides, Microscope

KALLESTAD LABORATORIES, INC.

The following data is part of a premarket notification filed by Kallestad Laboratories, Inc. with the FDA for Quantimetric 2 Test Kit.

Pre-market Notification Details

Device IDK813242
510k NumberK813242
Device Name:QUANTIMETRIC 2 TEST KIT
ClassificationSlides, Microscope
Applicant KALLESTAD LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKEW  
CFR Regulation Number864.3010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-11-17
Decision Date1981-12-02

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