ISO-SEP SYSTEM— 510(k) K842018

Substantially Equivalent

Berwick Medical Products, Inc.

FDA 510(k) clearance K842018 for ISO-SEP SYSTEM, Substantially Equivalent on 1984-09-28. Applicant: Berwick Medical Products, Inc.. Device class: 2.

Clearance details

Applicant: Berwick Medical Products, Inc.
Product code: Code CEX
Device class: Class 2
Regulation: 21 CFR 862.1445
Advisory panel: Clinical Chemistry
Date received: 1984-05-18
Decision date: 1984-09-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Berwick Medical Products, Inc.

K850800 — DROPSTIRS - PLASTIC DISPOSABLE PIPET1985-04-02
K831434 — ISO-SEP SYSTEM1983-06-30
K831289 — PREFILLED IEC COLUMNS1983-06-16
K830918 — I.E.C COLUMN1983-04-27

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