Cleared Traditional

FLUORESCEIN CONJUGATED ANTI-CHLAMYDIA MONO ANTI

K883352 · Whittaker Bioproducts, Inc. · Microbiology
Oct 1988
Decision
58d
Days
Class 1
Risk

About This 510(k) Submission

K883352 is an FDA 510(k) clearance for the FLUORESCEIN CONJUGATED ANTI-CHLAMYDIA MONO ANTI, a Antiserum, Fluorescent, Chlamydia Trachomatis (Class I — General Controls, product code LJP), submitted by Whittaker Bioproducts, Inc. (Walkersville, US). The FDA issued a Cleared decision on October 6, 1988, 58 days after receiving the submission on August 9, 1988. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3120.

Submission Details

510(k) Number K883352 FDA.gov
FDA Decision Cleared SESE
Date Received August 09, 1988
Decision Date October 06, 1988
Days to Decision 58 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code LJP — Antiserum, Fluorescent, Chlamydia Trachomatis
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3120

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