Cleared Traditional

K780464 - LELECTIVE KINETIC SYSTEM-60
(FDA 510(k) Clearance)

K780464 · Hycel, Inc. · Chemistry

May 1978

Decision

42d

Days

Class 1

Risk

K780464 is an FDA 510(k) clearance for the LELECTIVE KINETIC SYSTEM-60, a Analyzer, Chemistry (photometric, Discrete), For Clinical Use (Class I — General Controls, product code JJE), submitted by Hycel, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 3, 1978, 42 days after receiving the submission on March 22, 1978. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2160.

Submission Details

510(k) Number	K780464 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 22, 1978
Decision Date	May 03, 1978
Days to Decision	42 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