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510(k) K982251

SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT KIT by Sigma Diagnostics, Inc. — Product Code CDO

K982251 is an FDA 510(k) premarket notification submitted by Sigma Diagnostics, Inc. for the device "SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT KIT". The FDA issued a decision of Substantially Equivalent on August 18, 1998. The device falls under product code CDO (Acid, Uric, Uricase (U.V.)), a Class I device regulated under 21 CFR 862.1775. Sigma Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 1998
Date Received
June 26, 1998
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 Sigma Diagnostics, Inc.

  • K021162 — AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX D (August 30, 2002)
  • K020109 — SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL (February 6, 2002)
  • K013549 — SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971 (December 26, 2001)
  • K013544 — SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096 (November 15, 2001)
  • K013545 — SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221 (November 15, 2001)
  • K012410 — INFINITY HBA KIT, MODELS 537-A, 537-B (October 26, 2001)
  • K010652 — SIGMA DIAGNOSTICS SIGMA-CAL, MODEL S2936 (March 30, 2001)
  • K010158 — THROMBOMAX-HS WITH CALCIUM, MODEL T6540 (March 22, 2001)
  • K003267 — SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A (March 15, 2001)
  • K003328 — ACCUCLOT CONTROL I, MODEL A4089 (March 1, 2001)

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)
  • 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)
  • K932162 — URIC ACID TEST ITEM NUMBER 65422 (September 27, 1993)
  • 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)

FDA data resources