Cleared Traditional

CHLAMYSET ANTIBODY EIA

K864457 · Orion Corp. · Microbiology
Sep 1987
Decision
303d
Days
Class 1
Risk

About This 510(k) Submission

K864457 is an FDA 510(k) clearance for the CHLAMYSET ANTIBODY EIA, a Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) (Class I — General Controls, product code LJC), submitted by Orion Corp. (20101 Turku, FI). The FDA issued a Cleared decision on September 11, 1987, 303 days after receiving the submission on November 12, 1986. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3120.

Submission Details

510(k) Number K864457 FDA.gov
FDA Decision Cleared SESE
Date Received November 12, 1986
Decision Date September 11, 1987
Days to Decision 303 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

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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