UREA NITROGEN (BUN)— 510(k) K812341

Substantially Equivalent

Pointe Scientific, Inc.,

FDA 510(k) clearance K812341 for UREA NITROGEN (BUN), Substantially Equivalent on 1981-09-01. Applicant: Pointe Scientific, Inc.,. Device class: 2.

Clearance details

Applicant: Pointe Scientific, Inc.,
Product code: Code CDQ
Device class: Class 2
Regulation: 21 CFR 862.1770
Advisory panel: Clinical Chemistry
Date received: 1981-08-18
Decision date: 1981-09-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Pointe Scientific, Inc.,

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K070251 — CARBON DIOXIDE LIQUID STABLE REAGENT2007-04-30
K070207 — MULTI-ANALYTE CHEMISTRY CALIBRATOR2007-04-13
K070504 — AMMONIA/ALCOHOL CONTROL SET2007-04-11

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