Cleared Traditional

ELECTROPHORESIS DATA CENTER (EDC)

K860645 · Helena Laboratories · Chemistry

Dec 1986

Decision

300d

Days

Class 1

Risk

About This 510(k) Submission

K860645 is an FDA 510(k) clearance for the ELECTROPHORESIS DATA CENTER (EDC), a Densitometer/scanner (integrating, Reflectance, Tlc, Radiochromat.) Clinica (Class I — General Controls, product code JQT), submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on December 17, 1986, 300 days after receiving the submission on February 20, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2400.

Submission Details

510(k) Number	K860645 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 20, 1986
Decision Date	December 17, 1986
Days to Decision	300 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—

Device Classification

Product Code	JQT — Densitometer/scanner (integrating, Reflectance, Tlc, Radiochromat.) Clinica
Device Class	Class I — General Controls
CFR Regulation	21 CFR 862.2400