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510(k) K821741

URICACID by Biodynamics Corp. — Product Code KNK

K821741 is an FDA 510(k) premarket notification submitted by Biodynamics Corp. for the device "URICACID". The FDA issued a decision of Substantially Equivalent on July 2, 1982. The device falls under product code KNK (Acid, Uric, Uricase (Colorimetric)), a Class I device regulated under 21 CFR 862.1775. Biodynamics Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 1982
Date Received
June 14, 1982
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 Biodynamics Corp.

  • K051675 — BIODYNAMICS BIA 500 BIOMPEDANCE BODY COMPOSITION ANALYZER (March 16, 2006)
  • K884033 — BIODYNAMICS MODEL 200 BODY COMPOSITION ANALYZER (November 17, 1988)
  • K881631 — BIODYNAMICS AUTOTRANSFUSION RESERVOIR (September 9, 1988)
  • K881968 — BIODYNAMICS MODEL BI-400 BODY COMPOSITION ANALYZER (July 28, 1988)
  • K874361 — BIODYNAMICS MODEL BI-300 BODY COMPOSITION ANALYZER (March 16, 1988)
  • K873807 — AUTOTRANSFUSION APPARATUS (March 9, 1988)
  • K874034 — ADR-22 AUTOMATIC DIALYZER REPROCESSOR (October 23, 1987)
  • K870052 — INFUMIX MIXING CONTAINER (February 27, 1987)
  • K822716 — UNIVERSAL CENTRIFUGE (September 30, 1982)
  • K822715 — PLATELET CENTRIFUGE (September 30, 1982)

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