THROMBOSCREEN APTT REAGENT— 510(k) K891337

Substantially Equivalent

Pacific Hemostasis

FDA 510(k) clearance K891337 for THROMBOSCREEN APTT REAGENT, Substantially Equivalent on 1989-04-21. Applicant: Pacific Hemostasis. Device class: 2.

Clearance details

Applicant: Pacific Hemostasis
Product code: Code GFO
Device class: Class 2
Regulation: 21 CFR 864.7925
Advisory panel: Hematology
Date received: 1989-03-10
Decision date: 1989-04-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ventura, CA, US

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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.