UNIPAK BUN— 510(k) K771087

Substantially Equivalent

Harleco

FDA 510(k) clearance K771087 for UNIPAK BUN, Substantially Equivalent on 1977-07-21. Applicant: Harleco. Device class: 2.

Clearance details

Applicant: Harleco
Product code: Code CDW
Device class: Class 2
Regulation: 21 CFR 862.1770
Advisory panel: Clinical Chemistry
Date received: 1977-06-16
Decision date: 1977-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CDW

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K863425 — AMRESCO FLOW PAC UREA NITROGEN REAGENTS #13461986-10-01
K861775 — TWIN BUN/GLUCOSE1986-06-27
K860419 — UREA NITROGEN REAGENT SET1986-02-11

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K813038 — ULTRACHEM TP, ITEM #649741981-11-10
K813039 — ULTRACHEM E-CHOL, ITEM #650251981-11-10
K813040 — ULTRACHEM CA, ITEM #649751981-11-10

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