Cleared Traditional

COAGULASE PLASMA, HORSE & RABBIT EDTA

K833858 · Otisville Biotech, Inc. · Microbiology
Dec 1983
Decision
31d
Days
Class 1
Risk

About This 510(k) Submission

K833858 is an FDA 510(k) clearance for the COAGULASE PLASMA, HORSE & RABBIT EDTA, a Plasma, Coagulase, Human, Horse And Rabbit (Class I — General Controls, product code JTL), submitted by Otisville Biotech, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 8, 1983, 31 days after receiving the submission on November 7, 1983. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2160.

Submission Details

510(k) Number K833858 FDA.gov
FDA Decision Cleared SESE
Date Received November 07, 1983
Decision Date December 08, 1983
Days to Decision 31 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