AMYLASE REAGENT SET

Nephelometric, Amylase

ALTA DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Alta Diagnostics, Inc. with the FDA for Amylase Reagent Set.

Pre-market Notification Details

Device IDK790797
510k NumberK790797
Device Name:AMYLASE REAGENT SET
ClassificationNephelometric, Amylase
Applicant ALTA DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKHM  
CFR Regulation Number862.1070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-04-24
Decision Date1979-07-17

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