Cleared Traditional

ZINC PVA

K931383 · Remel Co. · Microbiology
Jun 1993
Decision
89d
Days
Class 1
Risk

About This 510(k) Submission

K931383 is an FDA 510(k) clearance for the ZINC PVA, a Device, Specimen Collection (Class I — General Controls, product code LIO), submitted by Remel Co. (Lenexa, US). The FDA issued a Cleared decision on June 15, 1993, 89 days after receiving the submission on March 18, 1993. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2900.

Submission Details

510(k) Number K931383 FDA.gov
FDA Decision Cleared SESE
Date Received March 18, 1993
Decision Date June 15, 1993
Days to Decision 89 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

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

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