Cleared Traditional

AMYLASE REAGENT CS-726

K844168 · Fisher Scientific Co., LLC · Chemistry
Nov 1984
Decision
26d
Days
Class 2
Risk

About This 510(k) Submission

K844168 is an FDA 510(k) clearance for the AMYLASE REAGENT CS-726, a Amyloclastic, Amylase (Class II — Special Controls, product code CJA), submitted by Fisher Scientific Co., LLC (Fair Lawn, US). The FDA issued a Cleared decision on November 20, 1984, 26 days after receiving the submission on October 25, 1984. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1070.

Submission Details

510(k) Number K844168 FDA.gov
FDA Decision Cleared SESE
Date Received October 25, 1984
Decision Date November 20, 1984
Days to Decision 26 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CJA — Amyloclastic, Amylase
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1070