Cleared Traditional

QUANTIMETRIX C-CLEAR(TM)

K931523 · Quantimetrix Corp. · Chemistry

Jun 1993

Decision

91d

Days

Class 1

Risk

About This 510(k) Submission

K931523 is an FDA 510(k) clearance for the QUANTIMETRIX C-CLEAR(TM), a Acid, Ascorbic, 2,4-dinitrophenylhydrazine (spectrophotometric) (Class I — General Controls, product code JMA), submitted by Quantimetrix Corp. (Hawthorne, US). The FDA issued a Cleared decision on June 25, 1993, 91 days after receiving the submission on March 26, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1095.

Submission Details

510(k) Number	K931523 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 26, 1993
Decision Date	June 25, 1993
Days to Decision	91 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement

Device Classification

Product Code	JMA — Acid, Ascorbic, 2,4-dinitrophenylhydrazine (spectrophotometric)
Device Class	Class I — General Controls
CFR Regulation	21 CFR 862.1095