AIA-PACK C-Peptide Control Set— 510(k) K143296

Substantially Equivalent

Tosoh Bioscience, Inc.

FDA 510(k) clearance K143296 for AIA-PACK C-Peptide Control Set, Substantially Equivalent on 2014-12-16. Applicant: Tosoh Bioscience, Inc..

Clearance details

Applicant: Tosoh Bioscience, Inc.
Product code: Code JJX
Advisory panel: Clinical Chemistry
Date received: 2014-11-17
Decision date: 2014-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South San Franciso, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JJX

product code JJX

Other: 2
Total: 2

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.