Cleared Traditional

PH-DETECT TEST

K952178 · Diagnostic Reagents, Inc. · Chemistry
Oct 1995
Decision
164d
Days
Class 1
Risk

About This 510(k) Submission

K952178 is an FDA 510(k) clearance for the PH-DETECT TEST, a Ph Meter (Class I — General Controls, product code JQY), submitted by Diagnostic Reagents, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on October 20, 1995, 164 days after receiving the submission on May 9, 1995. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2050.

Submission Details

510(k) Number K952178 FDA.gov
FDA Decision Cleared SESE
Date Received May 09, 1995
Decision Date October 20, 1995
Days to Decision 164 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JQY — Ph Meter
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2050

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