ULTRACHEM T.P.— 510(k) K821879

Substantially Equivalent

Harleco Diagnostics

FDA 510(k) clearance K821879 for ULTRACHEM T.P., Substantially Equivalent on 1982-07-14. Applicant: Harleco Diagnostics. Device class: 2.

Clearance details

Applicant: Harleco Diagnostics
Product code: Code CEX
Device class: Class 2
Regulation: 21 CFR 862.1445
Advisory panel: Clinical Chemistry
Date received: 1982-06-25
Decision date: 1982-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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K821871 — ULTRAZYME PLUS 2GT1982-07-14
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