Cleared Traditional

BIOKIT RPR

K910541 · Biokit USA, Inc. · Microbiology
Oct 1991
Decision
256d
Days
Class 2
Risk

About This 510(k) Submission

K910541 is an FDA 510(k) clearance for the BIOKIT RPR, a Antigens, Nontreponemal, All (Class II — Special Controls, product code GMQ), submitted by Biokit USA, Inc. (Barcelona, ES). The FDA issued a Cleared decision on October 18, 1991, 256 days after receiving the submission on February 4, 1991. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3820.

Submission Details

510(k) Number K910541 FDA.gov
FDA Decision Cleared SESE
Date Received February 04, 1991
Decision Date October 18, 1991
Days to Decision 256 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code GMQ — Antigens, Nontreponemal, All
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3820

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