REF. MEMBRANE FOR ORION 1020 SODIUM/POTASSIUM ANA.— 510(k) K864862

Name: FDA 510(k) clearance K864862
Creator: U.S. Food and Drug Administration
Published: 1987-02-20

Substantially Equivalent

Hf Scientific, Inc.

FDA 510(k) clearance K864862 for REF. MEMBRANE FOR ORION 1020 SODIUM/POTASSIUM ANA., Substantially Equivalent on 1987-02-20. Applicant: Hf Scientific, Inc.. Device class: 2.

Clearance details

Applicant: Hf Scientific, Inc.
Product code: Code JGS
Device class: Class 2
Regulation: 21 CFR 862.1665
Advisory panel: Clinical Chemistry
Date received: 1986-12-11
Decision date: 1987-02-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ft. Myers, FL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code JGS

product code JGS

Malfunction: 535
Total: 535

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.