ELECTRA(R) 800 AUTOMATIC COAGULATION TIMER— 510(k) K864534

Substantially Equivalent

Medical Laboratory Automation Systems, Inc.

FDA 510(k) clearance K864534 for ELECTRA(R) 800 AUTOMATIC COAGULATION TIMER, Substantially Equivalent on 1987-02-06. Applicant: Medical Laboratory Automation Systems, Inc..

Clearance details

Applicant: Medical Laboratory Automation Systems, Inc.
Product code: Code JPA
Advisory panel: Hematology
Date received: 1986-11-17
Decision date: 1987-02-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pleasantville, NY, US

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Adverse events under product code JPA

product code JPA

Death: 6
Total: 6

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.