Cleared Traditional

K801460 - PACIFIC HEMOSTASIS THROMBO-SCREEN KAPTT
(FDA 510(k) Clearance)

K801460 · Pacific Hemostasis · Hematology

Jul 1980

Decision

34d

Days

Class 2

Risk

K801460 is an FDA 510(k) clearance for the PACIFIC HEMOSTASIS THROMBO-SCREEN KAPTT, a Test, Time, Partial Thromboplastin (Class II — Special Controls, product code GGW), submitted by Pacific Hemostasis (Mchenry, US). The FDA issued a Cleared decision on July 28, 1980, 34 days after receiving the submission on June 24, 1980. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7925.

Submission Details

510(k) Number	K801460 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 24, 1980
Decision Date	July 28, 1980
Days to Decision	34 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	—