Cleared Traditional

POSITIVE AND NEGATIVE HCG SERUM CONTROLS

K896875 · Armkel, LLC · Chemistry
Feb 1990
Decision
80d
Days
Class 1
Risk

About This 510(k) Submission

K896875 is an FDA 510(k) clearance for the POSITIVE AND NEGATIVE HCG SERUM CONTROLS, a Single (specified) Analyte Controls (assayed And Unassayed) (Class I — General Controls, product code JJX), submitted by Armkel, LLC (Cranbury, US). The FDA issued a Cleared decision on February 26, 1990, 80 days after receiving the submission on December 8, 1989. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K896875 FDA.gov
FDA Decision Cleared SESE
Date Received December 08, 1989
Decision Date February 26, 1990
Days to Decision 80 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JJX — Single (specified) Analyte Controls (assayed And Unassayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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