Cleared Traditional

RPR TEST REDITEST

K843741 · Biokit USA, Inc. · Microbiology
Oct 1984
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K843741 is an FDA 510(k) clearance for the RPR TEST REDITEST, a Antisera, Control For Nontreponemal Tests (Class II — Special Controls, product code GMP), submitted by Biokit USA, Inc. (Barcelona, Spain, US). The FDA issued a Cleared decision on October 25, 1984, 30 days after receiving the submission on September 25, 1984. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3820.

Submission Details

510(k) Number K843741 FDA.gov
FDA Decision Cleared SESE
Date Received September 25, 1984
Decision Date October 25, 1984
Days to Decision 30 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code GMP — Antisera, Control For Nontreponemal Tests
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3820

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