Cleared Traditional

ELECTROLYTE STANDARDS

K960592 · Phoenix Diagnostics, Inc. · Chemistry
May 1996
Decision
91d
Days
Class 1
Risk

About This 510(k) Submission

K960592 is an FDA 510(k) clearance for the ELECTROLYTE STANDARDS, a Electrolyte Controls (assayed And Unassayed) (Class I — General Controls, product code JJR), submitted by Phoenix Diagnostics, Inc. (Natick, US). The FDA issued a Cleared decision on May 13, 1996, 91 days after receiving the submission on February 12, 1996. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K960592 FDA.gov
FDA Decision Cleared SESE
Date Received February 12, 1996
Decision Date May 13, 1996
Days to Decision 91 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JJR — Electrolyte Controls (assayed And Unassayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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