ULTRAZYME PLUS 2GT— 510(k) K821871

Substantially Equivalent

Harleco Diagnostics

FDA 510(k) clearance K821871 for ULTRAZYME PLUS 2GT, Substantially Equivalent on 1982-07-14. Applicant: Harleco Diagnostics. Device class: 1.

Clearance details

Applicant: Harleco Diagnostics
Product code: Code JPZ
Device class: Class 1
Regulation: 21 CFR 862.1360
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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More clearances from Harleco Diagnostics

K823147 — URIC ACID STANDARD, 8MG/DL #650781982-11-22
K822852 — TRIGLYCERIDE CALIBRATOR1982-10-27
K822323 — ULTRACHEM BUN-UV, 65080 & 650811982-09-02
K821872 — ULTRACHEM URIC ACID AIDH1982-07-14
K821873 — ULTRACHEM T-BILI1982-07-14

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