BIO-MEGA DIAGNOSTIC COATED TUBE IRMA TSH— 510(k) K864659

Substantially Equivalent

Bio Mega Diagnostic, Inc.

FDA 510(k) clearance K864659 for BIO-MEGA DIAGNOSTIC COATED TUBE IRMA TSH, Substantially Equivalent on 1987-02-04. Applicant: Bio Mega Diagnostic, Inc..

Clearance details

Applicant: Bio Mega Diagnostic, Inc.
Product code: Code JLW
Advisory panel: Clinical Chemistry
Date received: 1986-11-28
Decision date: 1987-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Canada, CA

Download summary PDF View on FDA.gov ↗

Adverse events under product code JLW

product code JLW

Malfunction: 885
Total: 885

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.