Cleared Traditional

PATHFINDER(TM) CHLAMYDIA MICROPLATE KIT

K902253 · Kallestad Diag, A Div. of Erbamont, Inc. · Microbiology
Jul 1990
Decision
66d
Days
Class 1
Risk

About This 510(k) Submission

K902253 is an FDA 510(k) clearance for the PATHFINDER(TM) CHLAMYDIA MICROPLATE KIT, a Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) (Class I — General Controls, product code LJC), submitted by Kallestad Diag, A Div. of Erbamont, Inc. (Chaska, US). The FDA issued a Cleared decision on July 26, 1990, 66 days after receiving the submission on May 21, 1990. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3120.

Submission Details

510(k) Number K902253 FDA.gov
FDA Decision Cleared SESE
Date Received May 21, 1990
Decision Date July 26, 1990
Days to Decision 66 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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