ULTRACHEM CREA— 510(k) K821881

Substantially Equivalent

Harleco Diagnostics

FDA 510(k) clearance K821881 for ULTRACHEM CREA, Substantially Equivalent on 1982-07-14. Applicant: Harleco Diagnostics.

Clearance details

Applicant: Harleco Diagnostics
Product code: Code CGX
Advisory panel: Clinical Chemistry
Date received: 1982-06-25
Decision date: 1982-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.