Cleared Traditional

AMYLASE REAGENT KIT

K812447 · Bioscientific · Chemistry
Sep 1981
Decision
12d
Days
Class 2
Risk

About This 510(k) Submission

K812447 is an FDA 510(k) clearance for the AMYLASE REAGENT KIT, a Nephelometric, Amylase (Class II — Special Controls, product code KHM), submitted by Bioscientific (Mchenry, US). The FDA issued a Cleared decision on September 9, 1981, 12 days after receiving the submission on August 28, 1981. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1070.

Submission Details

510(k) Number K812447 FDA.gov
FDA Decision Cleared SESE
Date Received August 28, 1981
Decision Date September 09, 1981
Days to Decision 12 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