Cleared Traditional

K873617 - GEMSTAR II SYSTEM
(FDA 510(k) Clearance)

K873617 · Electro-Nucleonics Laboratories, Inc. · Chemistry

Oct 1987

Decision

41d

Days

Class 1

Risk

K873617 is an FDA 510(k) clearance for the GEMSTAR II SYSTEM. This device is classified as a Analyzer, Chemistry (photometric, Discrete), For Clinical Use (Class I — General Controls, product code JJE).

Submitted by Electro-Nucleonics Laboratories, Inc. (Columbia, US). The FDA issued a Cleared decision on October 19, 1987, 41 days after receiving the submission on September 8, 1987.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2160.

Submission Details

510(k) Number	K873617 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 08, 1987
Decision Date	October 19, 1987
Days to Decision	41 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—

Device Classification

Product Code	JJE — Analyzer, Chemistry (photometric, Discrete), For Clinical Use
Device Class	Class I — General Controls
CFR Regulation	21 CFR 862.2160