Cleared Special

LIGHT DIAGNOSTICS PNEUMOCYSTIS CARINII DFA, MODEL 31965

K992252 · Chemicon Intl., Inc. · Microbiology
Aug 1999
Decision
35d
Days
Class 2
Risk

About This 510(k) Submission

K992252 is an FDA 510(k) clearance for the LIGHT DIAGNOSTICS PNEUMOCYSTIS CARINII DFA, MODEL 31965, a Pneumocystis Carinii (Class II — Special Controls, product code LYF), submitted by Chemicon Intl., Inc. (Temecula, US). The FDA issued a Cleared decision on August 10, 1999, 35 days after receiving the submission on July 6, 1999. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3780.

Submission Details

510(k) Number K992252 FDA.gov
FDA Decision Cleared SESE
Date Received July 06, 1999
Decision Date August 10, 1999
Days to Decision 35 days
Submission Type Special
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code LYF — Pneumocystis Carinii
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3780

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