Cleared Traditional

AMYLASE REAGENT #88129

K831295 · Hi Chem, Inc. · Chemistry
Jun 1983
Decision
71d
Days
Class 2
Risk

About This 510(k) Submission

K831295 is an FDA 510(k) clearance for the AMYLASE REAGENT #88129, a Nephelometric, Amylase (Class II — Special Controls, product code KHM), submitted by Hi Chem, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 30, 1983, 71 days after receiving the submission on April 20, 1983. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1070.

Submission Details

510(k) Number K831295 FDA.gov
FDA Decision Cleared SESE
Date Received April 20, 1983
Decision Date June 30, 1983
Days to Decision 71 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