ISO-SEP SYSTEM— 510(k) K831434

Name: FDA 510(k) clearance K831434
Creator: U.S. Food and Drug Administration
Published: 1983-06-30

Substantially Equivalent

Berwick Medical Products, Inc.

FDA 510(k) clearance K831434 for ISO-SEP SYSTEM, Substantially Equivalent on 1983-06-30. Applicant: Berwick Medical Products, Inc.. Device class: 2.

Clearance details

Applicant: Berwick Medical Products, Inc.
Product code: Code CDP
Device class: Class 2
Regulation: 21 CFR 862.1710
Advisory panel: Clinical Chemistry
Date received: 1983-05-04
Decision date: 1983-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K850800 — DROPSTIRS - PLASTIC DISPOSABLE PIPET1985-04-02
K842018 — ISO-SEP SYSTEM1984-09-28
K831289 — PREFILLED IEC COLUMNS1983-06-16
K830918 — I.E.C COLUMN1983-04-27

Adverse events under product code CDP

product code CDP

Malfunction: 647
Total: 647

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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