Cleared Traditional

TRU-LEVEL CONTROL IMMUNOASSAY CONTROLS

K861202 · Nms Pharmaceuticals, Inc. · Chemistry
Jan 1987
Decision
284d
Days
Class 1
Risk

About This 510(k) Submission

K861202 is an FDA 510(k) clearance for the TRU-LEVEL CONTROL IMMUNOASSAY CONTROLS, a Multi-analyte Controls, All Kinds (assayed) (Class I — General Controls, product code JJY), submitted by Nms Pharmaceuticals, Inc. (Newport Beach, US). The FDA issued a Cleared decision on January 9, 1987, 284 days after receiving the submission on March 31, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K861202 FDA.gov
FDA Decision Cleared SESE
Date Received March 31, 1986
Decision Date January 09, 1987
Days to Decision 284 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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