UREA NITROGEN TEST— 510(k) K863889

Substantially Equivalent

U. S. Diagnostics, Inc.

FDA 510(k) clearance K863889 for UREA NITROGEN TEST, Substantially Equivalent on 1986-11-24. Applicant: U. S. Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: U. S. Diagnostics, Inc.
Product code: Code CDL
Device class: Class 2
Regulation: 21 CFR 862.1770
Advisory panel: Clinical Chemistry
Date received: 1986-10-06
Decision date: 1986-11-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Luis Obispo, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CDL

K896845 — RAICHEM(TM) UREA NITROGEN (COLOR) REAGENT1990-02-16
K893128 — STANBIO ENZYMATIC UREA NITROGEN DETERMINAT #20101989-07-25
K871651 — COLORIMETRIC BUN REAGENT KIT1987-05-12
K864742 — UREA NITROGEN(BUN), COLORIMETRIC METHOD1987-01-13
K863076 — UREAFAST1986-09-09

More clearances from U. S. Diagnostics, Inc.

K110435 — EASYGLUCO PLUS BLOOD GLUCOSE MONITORING SYSTEM2011-09-21
K082201 — G5 INFINITY BLODO GLUCOSE MONITORING SYSTEM WITH MODEL IGM, 0024A2009-02-20
K061431 — EASYGLUCO, MODEL IGM-0002 G22007-01-12
K051651 — G4, MODEL IGM-00042006-04-14
K870596 — PROTHROMBIN TIME TEST1987-04-20

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