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510(k) K061588

VITROS CHEMISTRY PRODUCTS HCY REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 27, HCY PERFORMANCE VERIFIERS by Ortho-Clinical Diagnostics, Inc. — Product Code LPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 2006
Date Received
June 8, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Urinary Homocystine (Nonquantitative) Test System
Device Class
Class II
Regulation Number
862.1377
Review Panel
CH
Submission Type

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Other clearances for product code LPS

  • K123930 — VITROS CHEMISTRY PRODUCTS HCY 2 REAGENT, CALIBRATOR KIT 27, HCY 2 PERFORMANCE VE (May 15, 2013)
  • K121053 — DIAZYME HOMOCYSTEINE POC TEST KIT (July 31, 2012)
  • K121533 — ST AIA-PACK HOMOCYSTEINE; ST AIA-PACK HOMOCYSTEINE CALIBRATOR SET; AIA-PACK HOMO (June 15, 2012)
  • K113793 — HOMOCYSTEINE TEST (June 5, 2012)
  • K112790 — AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON (May 7, 2012)
  • K083222 — AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100 (July 31, 2009)
  • K080851 — A/C PORTABLE ENZYMATIC HOMOCYSTEINE ASSAY (October 10, 2008)
  • K073640 — ARCHITECT HOMOCYSTEINE REAGENTS, CALIBRATORS AND CONTROLS (April 24, 2008)
  • K071971 — DIAZYME HOMOCYSTEINE 2 REAGENT ENZYMATIC ASSAY KIT, AND CALIBRATORS, MODEL(S) DZ (September 17, 2007)
  • K063701 — TECO HOMOCYSTEINE ENZYMATIC ASSAY (April 11, 2007)