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510(k) K050790

SPOTCHEM II LDH TEST by Arkray, Inc. — Product Code CFH

K050790 is an FDA 510(k) premarket notification submitted by Arkray, Inc. for the device "SPOTCHEM II LDH TEST". The FDA issued a decision of Substantially Equivalent on June 6, 2005. The device falls under product code CFH (Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase), a Class II device regulated under 21 CFR 862.1440. Arkray, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 2005
Date Received
March 28, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase
Device Class
Class II
Regulation Number
862.1440
Review Panel
CH
Submission Type

Other clearances by Arkray, Inc.

  • K232416 — AUTION EYE AI-4510 Urine Particle Analysis System (May 3, 2024)
  • K193514 — AUTION MAX AX-4060 Urinalysis System (April 13, 2023)
  • K221175 — Multi-Lancet Device 2, ReliOn Premier Lancing Device (October 17, 2022)
  • K200788 — Assure Titanium Blood Glucose Monitoring System (May 23, 2022)
  • K160062 — AUTION ELEVEN Semi-Automated Urinalysis System (October 7, 2016)
  • K121456 — AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET (February 1, 2013)
  • K093098 — AUTION MAX MODEL AX-4030 URINALYSIS SYSTEM (December 23, 2009)
  • K053401 — SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTS (March 24, 2006)
  • K051648 — SPOTCHEM II INOGANIC PHOSPHORUS, CPK AND URIC ACID TESTS (January 31, 2006)
  • K051432 — SPOTCHEM II TOTAL BILIRUBIN, TOTAL PROTEIN AND ALBUMIN TESTS (June 17, 2005)

Other clearances for product code CFH

  • K020484 — CARESIDE LDH (July 3, 2002)
  • K895138 — CLINISTAT LDH REAGENT TEST (October 19, 1989)
  • K894578 — IQ LDH (October 17, 1989)
  • K880630 — LACTATE DEHYDROGENASE (LDH-L) (March 16, 1988)
  • K860349 — LACTATE DEHYDROGENASE (LDH) REAGENT SET (February 28, 1986)
  • K852391 — EDC/TITAN GELISO-DOT TOTAL LDH ISOENZYME PROCEDURE (October 1, 1985)
  • K842452 — WAKO LDH CII TEST (August 15, 1984)
  • K820768 — COLORIMETRIC LDH REAGENT SET (April 14, 1982)
  • K812836 — LDH REAGENT SET (October 9, 1981)
  • K782176 — HYCEL LDH-INT TEST (January 26, 1979)

FDA data resources