Home / 510(k) Clearances / K932162

510(k) K932162

URIC ACID TEST ITEM NUMBER 65422 by Em Diagnostic Systems, Inc. — Product Code CDO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 1993
Date Received
May 4, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Acid, Uric, Uricase (U.V.)
Device Class
Class I
Regulation Number
862.1775
Review Panel
CH
Submission Type

Other clearances by Em Diagnostic Systems, Inc.

  • K935181 — ASPARTATE AMINOTRANSFERASE (AST) TEST (January 27, 1994)
  • K935180 — ALANINE AMINOTRANSFERASE (ALT) TEST (January 13, 1994)
  • K935179 — EMDS ALBUMIN (ALB) TEST (December 17, 1993)
  • K935178 — EMDS PHOSPHOROUS (PHOS) TEST (December 17, 1993)
  • K935175 — LACTATE DEHYDROGENASE (LD) (December 16, 1993)
  • K935177 — GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST (December 16, 1993)
  • K935136 — CHOLESTEROL (CHOL) TEST ITEM NO. 65410 (December 16, 1993)
  • K935174 — TOTAL PROTEIN TEST (TPRO) (December 16, 1993)
  • K935176 — IRON TEST (December 16, 1993)
  • K935182 — EMDS ALKANINE PHOSPHATASE (ALP) TEST (December 9, 1993)

Other clearances for product code CDO

  • K033278 — RANDOX URIC ACID (February 27, 2004)
  • K992798 — SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT, MODELS 684-25, 684-100P, 684-500P, (September 28, 1999)
  • K982251 — SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT KIT (August 18, 1998)
  • K981766 — URIC ACID (June 19, 1998)
  • K981189 — URIC ACID (May 7, 1998)
  • K971485 — URIC ACID - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) (May 27, 1997)
  • K955752 — OLYMPUS URIC ACID REAGENT (January 31, 1996)
  • K923765 — SYSTEMATE URICACID TEST, TECHNICON RA 1000 (September 22, 1992)
  • K903335 — SYSTEMATE URIC ACID (URCA) ITEM NUMBER 65422 (August 17, 1990)
  • K875320 — BIOTROL URIC ACID ENZYMATIQUE UV H.P. (February 1, 1988)