Cleared Traditional

FLUORTRAN - C(TM)

K872751 · Para Scientific Co. · Microbiology
Jul 1987
Decision
10d
Days
Class 1
Risk

About This 510(k) Submission

K872751 is an FDA 510(k) clearance for the FLUORTRAN - C(TM), a Device, Specimen Collection (Class I — General Controls, product code LIO), submitted by Para Scientific Co. (Lake Oswego, US). The FDA issued a Cleared decision on July 23, 1987, 10 days after receiving the submission on July 13, 1987. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2900.

Submission Details

510(k) Number K872751 FDA.gov
FDA Decision Cleared SESE
Date Received July 13, 1987
Decision Date July 23, 1987
Days to Decision 10 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary

Device Classification

Product Code LIO — Device, Specimen Collection
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2900

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