DIRECT UREA NITROGEN TEST— 510(k) K780262

Substantially Equivalent

Hycel, Inc.

FDA 510(k) clearance K780262 for DIRECT UREA NITROGEN TEST, Substantially Equivalent on 1978-04-05. Applicant: Hycel, Inc.. Device class: 2.

Clearance details

Applicant: Hycel, Inc.
Product code: Code CDW
Device class: Class 2
Regulation: 21 CFR 862.1770
Advisory panel: Clinical Chemistry
Date received: 1978-02-17
Decision date: 1978-04-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CDW

K874532 — BLOOD UREA NITROGEN1988-01-05
K871320 — FLOW-PAC UREA NITROGEN REAGENT SET 2214, 28141987-04-22
K863425 — AMRESCO FLOW PAC UREA NITROGEN REAGENTS #13461986-10-01
K861775 — TWIN BUN/GLUCOSE1986-06-27
K860419 — UREA NITROGEN REAGENT SET1986-02-11

More clearances from Hycel, Inc.

K802422 — HYCEL TRIGYCERIDE II TEST1980-10-06
K790335 — HYCEL M1979-02-27
K782116 — KETOSTEROID TEST, HYCEL-171979-01-26
K782176 — HYCEL LDH-INT TEST1979-01-26
K782100 — HYCEL COUNTER 3331979-01-03

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