Cleared Traditional

WASH SOLUTION KIT

K873130 · A-Kem, Inc. · Chemistry
Oct 1987
Decision
74d
Days
Class 1
Risk

About This 510(k) Submission

K873130 is an FDA 510(k) clearance for the WASH SOLUTION KIT, a Analyzer, Chemistry (photometric, Discrete), For Clinical Use (Class I — General Controls, product code JJE), submitted by A-Kem, Inc. (Clifton, US). The FDA issued a Cleared decision on October 23, 1987, 74 days after receiving the submission on August 10, 1987. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2160.

Submission Details

510(k) Number K873130 FDA.gov
FDA Decision Cleared SESE
Date Received August 10, 1987
Decision Date October 23, 1987
Days to Decision 74 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JJE — Analyzer, Chemistry (photometric, Discrete), For Clinical Use
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2160

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