ULTRACHEM CREA ITEM #64972— 510(k) K813043

Substantially Equivalent

Harleco

FDA 510(k) clearance K813043 for ULTRACHEM CREA ITEM #64972, Substantially Equivalent on 1981-11-10. Applicant: Harleco. Device class: 2.

Clearance details

Applicant: Harleco
Product code: Code CGX
Device class: Class 2
Regulation: 21 CFR 862.1225
Advisory panel: Clinical Chemistry
Date received: 1981-10-28
Decision date: 1981-11-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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