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510(k) K821167

URICASE (U.V.) URIC ACID by Syn-Kit, Inc. — Product Code CDO

K821167 is an FDA 510(k) premarket notification submitted by Syn-Kit, Inc. for the device "URICASE (U.V.) URIC ACID". The FDA issued a decision of Substantially Equivalent on May 14, 1982. The device falls under product code CDO (Acid, Uric, Uricase (U.V.)), a Class I device regulated under 21 CFR 862.1775. Syn-Kit, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 1982
Date Received
April 27, 1982
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 Syn-Kit, Inc.

  • K861098 — SEROIDEN STREPTO KIT 'EIKEN' (August 12, 1986)
  • K861631 — SLIDE CULTURE U 'EIKEN' (June 10, 1986)
  • K854819 — CPR SLIDE EIKEN (February 26, 1986)
  • K854820 — RA 80 EIKEN (January 17, 1986)
  • K853276 — ASO SLIDE EIKEN (August 20, 1985)
  • K843760 — UROPAPER EIKEN G (December 18, 1984)
  • K843757 — UROPAPER EIKEN AG (December 18, 1984)
  • K843753 — UROPAPER EIKEN GP (December 18, 1984)
  • K843758 — UROPAPER EIKEN GK (December 18, 1984)
  • K843755 — UROPAPER EIKEN 6B (December 18, 1984)

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)
  • 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)

FDA data resources