Cleared Traditional

PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR V DEFICIENT PLASMA (THROMBOSDREEN BRAND) (100056)

K972627 · Pacific Hemostasis · Hematology

Aug 1997

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K972627 is an FDA 510(k) clearance for the PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR V DEFICIENT PLASMA (THROMBOSDREEN BRAND) (100056), a Plasma, Coagulation Factor Deficient (Class II — Special Controls, product code GJT), submitted by Pacific Hemostasis (Huntersville, US). The FDA issued a Cleared decision on August 13, 1997, 30 days after receiving the submission on July 14, 1997. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7290.

Submission Details

510(k) Number	K972627 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 14, 1997
Decision Date	August 13, 1997
Days to Decision	30 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Summary PDF