FLEXSURE HP,CONTROLS FOR FLEXSUREHP,FLEXPACK HP(ABBOTT DIAGNOSTICS)ANDCONTROLS FOR FLEXPACK HP (ABBOTT DIAGNOSTICS)— 510(k) K960183

Substantially Equivalent

Smithkline Diagnostics, Inc.

FDA 510(k) clearance K960183 for FLEXSURE HP,CONTROLS FOR FLEXSUREHP,FLEXPACK HP(ABBOTT DIAGNOSTICS)ANDCONTROLS FOR FLEXPACK HP (ABBOTT DIAGNOSTICS), Substantially Equivalent on 1996-06-07. Applicant: Smithkline Diagnostics, Inc..

Clearance details

Applicant: Smithkline Diagnostics, Inc.
Product code: Code LYR
Advisory panel: Microbiology
Date received: 1996-01-16
Decision date: 1996-06-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LYR

product code LYR

Other: 1
Total: 1

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.