ULTRACHEM BUN-UV, 65080 & 65081— 510(k) K822323

Name: FDA 510(k) clearance K822323
Creator: U.S. Food and Drug Administration
Published: 1982-09-02

Substantially Equivalent

Harleco Diagnostics

FDA 510(k) clearance K822323 for ULTRACHEM BUN-UV, 65080 & 65081, Substantially Equivalent on 1982-09-02. Applicant: Harleco Diagnostics. Device class: 2.

Clearance details

Applicant: Harleco Diagnostics
Product code: Code CDW
Device class: Class 2
Regulation: 21 CFR 862.1770
Advisory panel: Clinical Chemistry
Date received: 1982-08-03
Decision date: 1982-09-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K861775 — TWIN BUN/GLUCOSE1986-06-27
K860419 — UREA NITROGEN REAGENT SET1986-02-11

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K821872 — ULTRACHEM URIC ACID AIDH1982-07-14
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