Cleared Traditional

K820450 - THROMBOSCREEN
(FDA 510(k) Clearance)

K820450 · Pacific Hemostasis · Hematology
Mar 1982
Decision
36d
Days
Class 2
Risk

K820450 is an FDA 510(k) clearance for the THROMBOSCREEN, a Reagent & Control, Partial Thromboplastin Time (Class II — Special Controls, product code GIT), submitted by Pacific Hemostasis (Mchenry, US). The FDA issued a Cleared decision on March 26, 1982, 36 days after receiving the submission on February 18, 1982. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7925.

Submission Details

510(k) Number K820450 FDA.gov
FDA Decision Cleared SESE
Date Received February 18, 1982
Decision Date March 26, 1982
Days to Decision 36 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code GIT — Reagent & Control, Partial Thromboplastin Time
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7925