Cleared Traditional

NORMAL AND ABNORMAL CONTROL SERA

K895943 · Sclavo, Inc. · Chemistry
Dec 1989
Decision
77d
Days
Class 1
Risk

About This 510(k) Submission

K895943 is an FDA 510(k) clearance for the NORMAL AND ABNORMAL CONTROL SERA, a Multi-analyte Controls, All Kinds (assayed) (Class I — General Controls, product code JJY), submitted by Sclavo, Inc. (Wayne, US). The FDA issued a Cleared decision on December 27, 1989, 77 days after receiving the submission on October 11, 1989. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K895943 FDA.gov
FDA Decision Cleared SESE
Date Received October 11, 1989
Decision Date December 27, 1989
Days to Decision 77 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JJY — Multi-analyte Controls, All Kinds (assayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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