MODEL AM 721 ELECTROLYTE ANALYZER— 510(k) K810135

Substantially Equivalent

Abbott Diagnostics

FDA 510(k) clearance K810135 for MODEL AM 721 ELECTROLYTE ANALYZER, Substantially Equivalent on 1981-02-10. Applicant: Abbott Diagnostics.

Clearance details

Applicant: Abbott Diagnostics
Product code: Code JGS
Advisory panel: Clinical Chemistry
Date received: 1981-01-21
Decision date: 1981-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

Download summary PDF View on FDA.gov ↗

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.