Cleared Traditional

AMYLASE REAGENT SET

K790797 · Alta Diagnostics, Inc. · Chemistry
Jul 1979
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K790797 is an FDA 510(k) clearance for the AMYLASE REAGENT SET, a Nephelometric, Amylase (Class II — Special Controls, product code KHM), submitted by Alta Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 17, 1979, 84 days after receiving the submission on April 24, 1979. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1070.

Submission Details

510(k) Number K790797 FDA.gov
FDA Decision Cleared SESE
Date Received April 24, 1979
Decision Date July 17, 1979
Days to Decision 84 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code KHM — Nephelometric, Amylase
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1070