Cleared Traditional

RPR LIQUID CONTROLS

K955143 · Remel, L.P. · Microbiology
Jul 1996
Decision
260d
Days
Class 2
Risk

About This 510(k) Submission

K955143 is an FDA 510(k) clearance for the RPR LIQUID CONTROLS, a Antisera, Control For Nontreponemal Tests (Class II — Special Controls, product code GMP), submitted by Remel, L.P. (Augusta, US). The FDA issued a Cleared decision on July 30, 1996, 260 days after receiving the submission on November 13, 1995. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3820.

Submission Details

510(k) Number K955143 FDA.gov
FDA Decision Cleared SESE
Date Received November 13, 1995
Decision Date July 30, 1996
Days to Decision 260 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

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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