Cleared Traditional

RABBIT PLASMA FIBRINOGEN SUPPLEMENT SR 122

K870945 · Oxoid U.S.A., Inc. · Microbiology
Jun 1987
Decision
93d
Days
Class 1
Risk

About This 510(k) Submission

K870945 is an FDA 510(k) clearance for the RABBIT PLASMA FIBRINOGEN SUPPLEMENT SR 122, a Plasma, Coagulase, Human, Horse And Rabbit (Class I — General Controls, product code JTL), submitted by Oxoid U.S.A., Inc. (Columbia, US). The FDA issued a Cleared decision on June 10, 1987, 93 days after receiving the submission on March 9, 1987. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2160.

Submission Details

510(k) Number K870945 FDA.gov
FDA Decision Cleared SESE
Date Received March 09, 1987
Decision Date June 10, 1987
Days to Decision 93 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code JTL — Plasma, Coagulase, Human, Horse And Rabbit
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2160