BLOOD UREA NITROGEN (BUN) TESTCARD— 510(k) K860543

Substantially Equivalent

Ilex Corp.

FDA 510(k) clearance K860543 for BLOOD UREA NITROGEN (BUN) TESTCARD, Substantially Equivalent on 1986-04-21. Applicant: Ilex Corp.. Device class: 2.

Clearance details

Applicant: Ilex Corp.
Product code: Code CDS
Device class: Class 2
Regulation: 21 CFR 862.1770
Advisory panel: Clinical Chemistry
Date received: 1986-02-13
Decision date: 1986-04-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Attleboro, MA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Ilex Corp.

K860639 — IONIZED CALCIUM AND BLOOD PH TESTCARDS1986-04-21
K853068 — ILEX PROMPT CLINICAL CHEMISTRY ANALYER1985-10-31

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