Cleared Traditional

RABBIT PLASMA FIBRINOGEN (RPF) SUPPLEMENT

K883333 · Immuno-Mycologics, Inc. · Microbiology
Aug 1988
Decision
16d
Days
Class 1
Risk

About This 510(k) Submission

K883333 is an FDA 510(k) clearance for the RABBIT PLASMA FIBRINOGEN (RPF) SUPPLEMENT, a Plasma, Coagulase, Human, Horse And Rabbit (Class I — General Controls, product code JTL), submitted by Immuno-Mycologics, Inc. (Norman, US). The FDA issued a Cleared decision on August 25, 1988, 16 days after receiving the submission on August 9, 1988. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2160.

Submission Details

510(k) Number K883333 FDA.gov
FDA Decision Cleared SESE
Date Received August 09, 1988
Decision Date August 25, 1988
Days to Decision 16 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