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510(k) K801898

URIC ACID DIAGNOSTIC REAGENT by Connecticut Diagnostics, Ltd. — Product Code KNK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 1980
Date Received
August 8, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Connecticut Diagnostics, Ltd.

  • K905617 — VISI-STAPH (March 29, 1991)
  • K822504 — CDL AUTO-LYSING REAGENT (September 17, 1982)
  • K822501 — CDL ISOTONIC DILUENT (September 17, 1982)
  • K822500 — CDL LYSING REAGENT (September 17, 1982)
  • K811222 — INORGANIC PHOSPHORUS REAGENTS (May 21, 1981)
  • K801897 — GLUCOSE DIAGNOSTIC REAGENT (October 10, 1980)
  • K792465 — CONNECTICUT DIAGNOSTICS, LTS. DIRECT (December 18, 1979)
  • K792339 — CONNECT. DIAG. ALBUMIN DIAGNOSTIC REAGEN (December 6, 1979)
  • K792362 — BLOOD UREA NITROGEN REAGENT (December 6, 1979)
  • K792340 — CONNECT. DIAG. TOTAL PROTEIN DIAG. REAGE (December 6, 1979)

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  • K040467 — VITALAB URIC ACID REAGENT (March 8, 2004)
  • K031044 — ATAC PAK URIC ACID REAGENT AND ATAC CALIBRATOR (July 15, 2003)
  • K022096 — URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (March 18, 2003)
  • K023550 — WIENER LAB URICOSTAT ENZIMATICO AA LIQUIDA (December 9, 2002)
  • K012038 — JAS URIC ACID LIQUID REAGENT (August 21, 2001)
  • K010421 — WIENER LAB. URICOSTAT ENZIMATICO AA, MODELS 2X50 ML CATALOGUE NO 1840106 AND 4X5 (April 13, 2001)
  • K993469 — WAKO L-TYPE UA F TEST (November 9, 1999)
  • K991247 — URIC ACID, MODEL UA112-01 (May 25, 1999)