Cleared Traditional

CONTACT-K APTT REAGENT

K834086 · Pacific Hemostasis · Microbiology
Feb 1984
Decision
67d
Days
Class 2
Risk

About This 510(k) Submission

K834086 is an FDA 510(k) clearance for the CONTACT-K APTT REAGENT, a Plasma, Coagulation Control (Class II — Special Controls, product code GGN), submitted by Pacific Hemostasis (Mchenry, US). The FDA issued a Cleared decision on February 3, 1984, 67 days after receiving the submission on November 28, 1983. This device falls under the Microbiology review panel. Regulated under 21 CFR 864.5425.

Submission Details

510(k) Number K834086 FDA.gov
FDA Decision Cleared SESE
Date Received November 28, 1983
Decision Date February 03, 1984
Days to Decision 67 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code GGN — Plasma, Coagulation Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5425

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