URICASE (U.V.) URIC ACID— 510(k) K821167

Substantially Equivalent

Syn-Kit, Inc.

FDA 510(k) clearance K821167 for URICASE (U.V.) URIC ACID, Substantially Equivalent on 1982-05-14. Applicant: Syn-Kit, Inc.. Device class: 1.

Clearance details

Applicant: Syn-Kit, Inc.
Product code: Code CDO
Device class: Class 1
Regulation: 21 CFR 862.1775
Advisory panel: Clinical Chemistry
Date received: 1982-04-27
Decision date: 1982-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CDO

K033278 — RANDOX URIC ACID2004-02-27
K992798 — SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT, MODELS 684-25, 684-100P, 684-500P, 684-2000P, 683-20, 683-100P1999-09-28
K982251 — SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT KIT1998-08-18
K981766 — URIC ACID1998-06-19
K981189 — URIC ACID1998-05-07

More clearances from Syn-Kit, Inc.

K861098 — SEROIDEN STREPTO KIT 'EIKEN'1986-08-12
K861631 — SLIDE CULTURE U 'EIKEN'1986-06-10
K854819 — CPR SLIDE EIKEN1986-02-26
K854820 — RA 80 EIKEN1986-01-17
K853276 — ASO SLIDE EIKEN1985-08-20

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