BUN COLOR REAGENT & BUN ACID USED— 510(k) K802160

Substantially Equivalent

Panmed, Inc.

FDA 510(k) clearance K802160 for BUN COLOR REAGENT & BUN ACID USED, Substantially Equivalent on 1980-10-10. Applicant: Panmed, Inc.. Device class: 2.

Clearance details

Applicant: Panmed, Inc.
Product code: Code CDW
Device class: Class 2
Regulation: 21 CFR 862.1770
Advisory panel: Clinical Chemistry
Date received: 1980-09-08
Decision date: 1980-10-10
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 Panmed, Inc.

K852767 — ERYTHOCYTE CREATINE1986-11-13
K820642 — SICKLE-CHECK1982-04-14
K802154 — REAGENTS USED-QUAN. MEASURE OF SERUM1980-10-10
K802155 — REAGENTS SERUM SODIUM USING THE TECH.1980-10-10
K802156 — REAGENTS SERUM CREATINE USING TECHICON1980-10-10

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