DOCUMENT TOTAL AND DIRECT BILIRUBIN LINEARITY-MOD— 510(k) K924493

Substantially Equivalent

Casco Standards

FDA 510(k) clearance K924493 for DOCUMENT TOTAL AND DIRECT BILIRUBIN LINEARITY-MOD, Substantially Equivalent on 1993-01-11. Applicant: Casco Standards.

Clearance details

Applicant: Casco Standards
Product code: Code JJX
Advisory panel: Clinical Chemistry
Date received: 1992-08-28
Decision date: 1993-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yarmouth, ME, 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.