PACIFIC HEMOSTASIS THROMBO-SCREEN KAPTT— 510(k) K801460

Name: FDA 510(k) clearance K801460
Creator: U.S. Food and Drug Administration
Published: 1980-07-28

Substantially Equivalent

Pacific Hemostasis

FDA 510(k) clearance K801460 for PACIFIC HEMOSTASIS THROMBO-SCREEN KAPTT, Substantially Equivalent on 1980-07-28. Applicant: Pacific Hemostasis. Device class: 2.

Clearance details

Applicant: Pacific Hemostasis
Product code: Code GGW
Device class: Class 2
Regulation: 21 CFR 864.7925
Advisory panel: Hematology
Date received: 1980-06-24
Decision date: 1980-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GGW

view all

K260551 — HemosIL Factor V Leiden (APC Resistance V)2026-03-20
K090105 — LUPOTEK KCT2010-12-30
K083729 — HEMOCLOT QUANTI- V-L, FACTOR V-L CALIBRATOR, BIOPHEN V-L CAL (UNDILUTED), BIOPHEN ACT. PC-R CONTROL PLASMA AND BIOPHEN2009-05-08
K060284 — CRYOCHECK CLOT APCR2006-05-10
K042762 — PEFAKIT APC-R FACTOR V LEIDEN2004-12-22

More clearances from Pacific Hemostasis

view all

K000679 — THROMBOSTRATE CONTROL PLASMAS2000-03-24
K994100 — PACIFIC HEMOSTASIS THROMBOPLASTIN D2000-02-18
K992130 — PACIFIC HEMOSTASIS THROMBOSCREEN 400C1999-09-03
K992278 — HEPARIN CONTROL PLASMA LEVEL 11999-08-26
K992279 — HEPARIN CONTROL PLASMA LEVEL 21999-08-26

Data sourced from openFDA. This site is unofficial and independent of the FDA.