ASSAY KIT, THROMBO-SCREEN— 510(k) K781880

Substantially Equivalent

Pacific Hemostasis

FDA 510(k) clearance K781880 for ASSAY KIT, THROMBO-SCREEN, Substantially Equivalent on 1978-12-04. Applicant: Pacific Hemostasis. Device class: 2.

Clearance details

Applicant: Pacific Hemostasis
Product code: Code GIS
Device class: Class 2
Regulation: 21 CFR 864.7340
Advisory panel: Hematology
Date received: 1978-11-06
Decision date: 1978-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GIS

K143470 — Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control Set2016-01-31
K042919 — FIBROTEK FIB2004-11-29
K993482 — K-ASSAY FIBRINOGEN1999-12-06
K963902 — QUANTITATIVE FIBRINOGEN ASSAY1996-11-29
K941001 — ENZIP IMMUNOTURBIDMETRIC FIBRINOGEN ASSAY KIT1994-08-30

More clearances from Pacific Hemostasis

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.