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510(k) K801898

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

K801898 is an FDA 510(k) premarket notification submitted by Connecticut Diagnostics, Ltd. for the device "URIC ACID DIAGNOSTIC REAGENT". The FDA issued a decision of Substantially Equivalent on October 10, 1980. The device falls under product code KNK (Acid, Uric, Uricase (Colorimetric)), a Class I device regulated under 21 CFR 862.1775. Connecticut Diagnostics, Ltd. has at least 10 other 510(k) clearances on record.

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)
  • K822500 — CDL LYSING REAGENT (September 17, 1982)
  • K822501 — CDL ISOTONIC DILUENT (September 17, 1982)
  • K822504 — CDL AUTO-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)
  • K792337 — DONNECT. DIAG. CALCIUM DIAG. REAGENT (December 6, 1979)
  • K792362 — BLOOD UREA NITROGEN REAGENT (December 6, 1979)

Other clearances for product code KNK

  • K102568 — URIC ACID MODEL 3P39 (May 6, 2011)
  • K062862 — OLYMPUS URIC ACID REAGENT, MODEL OSR6X98 (April 6, 2007)
  • 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)

FDA data resources