CLINALYZER MODEL VX-1000— 510(k) K851638

Substantially Equivalent

Alpkem Corp.

FDA 510(k) clearance K851638 for CLINALYZER MODEL VX-1000, Substantially Equivalent on 1985-05-13. Applicant: Alpkem Corp..

Clearance details

Applicant: Alpkem Corp.
Product code: Code JJE
Advisory panel: Clinical Chemistry
Date received: 1985-04-19
Decision date: 1985-05-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clackamas, OR, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JJE

product code JJE

Death: 6
Injury: 441
Malfunction: 25,011
Other: 1
Total: 25,459

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.