PLASMA EXTRACTION SYSTEM— 510(k) K850391

Name: FDA 510(k) clearance K850391
Creator: U.S. Food and Drug Administration
Published: 1985-05-10

Substantially Equivalent

Hans J. Brouwers & Assoc.

FDA 510(k) clearance K850391 for PLASMA EXTRACTION SYSTEM, Substantially Equivalent on 1985-05-10. Applicant: Hans J. Brouwers & Assoc.. Device class: 2.

Clearance details

Applicant: Hans J. Brouwers & Assoc.
Product code: Code JPI
Device class: Class 2
Regulation: 21 CFR 864.6400
Advisory panel: Hematology
Date received: 1985-02-01
Decision date: 1985-05-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mount Prospect, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JPI

view all

K183680 — i-STAT CHEM8+ cartridge with the i-STAT 1 System2020-02-28
K163342 — i-STAT Hematocrit test with i-STAT Alinity System2017-08-22
K950942 — CRIT-LINE HEMATOCRIT ALERT1995-03-14
K924167 — CRIT-LINE1993-05-07
K903698 — STATSPIN MICRO-HEMATOCRIT READER FOR 75MM TUBES1990-09-17

More clearances from Hans J. Brouwers & Assoc.

view all

K850390 — CHOLESTEROL TEST SYSTEM1985-07-09

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