REAGENTS FOR TSH ASSAY— 510(k) K881381

Substantially Equivalent

Sclavo, Inc.

FDA 510(k) clearance K881381 for REAGENTS FOR TSH ASSAY, Substantially Equivalent on 1988-07-21. Applicant: Sclavo, Inc..

Clearance details

Applicant: Sclavo, Inc.
Product code: Code JLW
Advisory panel: Clinical Chemistry
Date received: 1988-04-01
Decision date: 1988-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

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.