Cleared Traditional

CHLAMYDIA IGG ELISA TEST SYSTEM

K962558 · Armkel, LLC · Microbiology
Feb 1997
Decision
238d
Days
Class 1
Risk

About This 510(k) Submission

K962558 is an FDA 510(k) clearance for the CHLAMYDIA IGG ELISA TEST SYSTEM, a Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) (Class I — General Controls, product code LJC), submitted by Armkel, LLC (Frederick, US). The FDA issued a Cleared decision on February 24, 1997, 238 days after receiving the submission on July 1, 1996. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3120.

Submission Details

510(k) Number K962558 FDA.gov
FDA Decision Cleared SESE
Date Received July 01, 1996
Decision Date February 24, 1997
Days to Decision 238 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LJC — Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group)
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3120

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