Cleared Traditional

TARGET READER

K885254 · V-Tech, Inc. · Chemistry

Jan 1989

Decision

35d

Days

Class 1

Risk

About This 510(k) Submission

K885254 is an FDA 510(k) clearance for the TARGET READER, a Densitometer/scanner (integrating, Reflectance, Tlc, Radiochromat.) Clinica (Class I — General Controls, product code JQT), submitted by V-Tech, Inc. (Pomona, US). The FDA issued a Cleared decision on January 27, 1989, 35 days after receiving the submission on December 23, 1988. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2400.

Submission Details

510(k) Number	K885254 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 23, 1988
Decision Date	January 27, 1989
Days to Decision	35 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