Cleared Traditional

PATHFINDER(TM) CHLAMYDIA EIA DETECT KIT/MODIFIED

K884517 · Kallestad Diag, A Div. of Erbamont, Inc. · Microbiology
Nov 1988
Decision
34d
Days
Class 1
Risk

About This 510(k) Submission

K884517 is an FDA 510(k) clearance for the PATHFINDER(TM) CHLAMYDIA EIA DETECT KIT/MODIFIED, 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 November 30, 1988, 34 days after receiving the submission on October 27, 1988. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3120.

Submission Details

510(k) Number K884517 FDA.gov
FDA Decision Cleared SESE
Date Received October 27, 1988
Decision Date November 30, 1988
Days to Decision 34 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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