510(k) K883640— KD ONE-STAGE PROTHROMBIN TIME TEST

Substantially Equivalent

King Diagnostics, Inc.

Clearance details

Applicant: King Diagnostics, Inc.
Product code: Code JPA
Advisory panel: Hematology
Date received: 1988-08-25
Decision date: 1988-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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.