EMDS URIC ACID (URC A) TESTPACK, ITEM #67664/95— 510(k) K863660

Name: FDA 510(k) clearance K863660
Creator: U.S. Food and Drug Administration
Published: 1986-10-29

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K863660 for EMDS URIC ACID (URC A) TESTPACK, ITEM #67664/95, Substantially Equivalent on 1986-10-29. Applicant: Em Diagnostic Systems, Inc.. Device class: 1.

Clearance details

Applicant: Em Diagnostic Systems, Inc.
Product code: Code CDO
Device class: Class 1
Regulation: 21 CFR 862.1775
Advisory panel: Clinical Chemistry
Date received: 1986-09-18
Decision date: 1986-10-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CDO

view all

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 Em Diagnostic Systems, Inc.

view all

K935181 — ASPARTATE AMINOTRANSFERASE (AST) TEST1994-01-27
K935180 — ALANINE AMINOTRANSFERASE (ALT) TEST1994-01-13
K935178 — EMDS PHOSPHOROUS (PHOS) TEST1993-12-17
K935179 — EMDS ALBUMIN (ALB) TEST1993-12-17
K935136 — CHOLESTEROL (CHOL) TEST ITEM NO. 654101993-12-16

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