Cleared Traditional

K831624 - GLUCOSE REAGENT KITS-B6370-10A
(FDA 510(k) Clearance)

K831624 · American Scientific Products · Chemistry

Jul 1983

Decision

47d

Days

Class 2

Risk

K831624 is an FDA 510(k) clearance for the GLUCOSE REAGENT KITS-B6370-10A. This device is classified as a Glucose Oxidase, Glucose (Class II — Special Controls, product code CGA).

Submitted by American Scientific Products (Mchenry, US). The FDA issued a Cleared decision on July 6, 1983, 47 days after receiving the submission on May 20, 1983.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number	K831624 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 20, 1983
Decision Date	July 06, 1983
Days to Decision	47 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—