Cleared Traditional

K862640 - AMYLASE LTS
(FDA 510(k) Clearance)

K862640 · Electro-Nucleonics Laboratories, Inc. · Chemistry

Sep 1986

Decision

61d

Days

Class 2

Risk

K862640 is an FDA 510(k) clearance for the AMYLASE LTS. This device is classified as a Amyloclastic, Amylase (Class II — Special Controls, product code CJA).

Submitted by Electro-Nucleonics Laboratories, Inc. (Columbia, US). The FDA issued a Cleared decision on September 9, 1986, 61 days after receiving the submission on July 10, 1986.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1070.

Submission Details

510(k) Number	K862640 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 10, 1986
Decision Date	September 09, 1986
Days to Decision	61 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—