ANTITHROMBIN III SCREEN KIT— 510(k) K812215

Substantially Equivalent

Pacific Hemostasis

FDA 510(k) clearance K812215 for ANTITHROMBIN III SCREEN KIT, Substantially Equivalent on 1981-09-01. Applicant: Pacific Hemostasis. Device class: 2.

Clearance details

Applicant: Pacific Hemostasis
Product code: Code JBQ
Device class: Class 2
Regulation: 21 CFR 864.7060
Advisory panel: Hematology
Date received: 1981-08-05
Decision date: 1981-09-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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More clearances from Pacific Hemostasis

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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.