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510(k) K011692

HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT by Intersect Systems, Inc. — Product Code LPS

K011692 is an FDA 510(k) premarket notification submitted by Intersect Systems, Inc. for the device "HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT". The FDA issued a decision of Substantially Equivalent on July 25, 2001. The device falls under product code LPS (Urinary Homocystine (Nonquantitative) Test System), a Class II device regulated under 21 CFR 862.1377. Intersect Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 2001
Date Received
May 31, 2001
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

Other clearances by Intersect Systems, Inc.

  • K021636 — ALBUMIN REAGENT (July 17, 2002)
  • K011972 — DIRECT BILIRUBIN REAGENT (August 27, 2001)
  • K003892 — TOTAL BILIRUBIN REAGENT (February 20, 2001)
  • K983937 — DUAL VIAL CREATININE REAGENT (January 6, 1999)
  • K974833 — CK-NAC REAGENT (February 13, 1998)
  • K941807 — INTERSECT SYSTEMS' NON-MERCURIC CHLORIDE REAGENT (September 14, 1994)
  • K932888 — INTERSECT SYSTEMS DIRECT AMYLASE REAGENT (January 31, 1994)
  • K934039 — INTERSECT SYSTEMS HDL CHOLESTEROL REAGENT SET (November 16, 1993)
  • K932267 — ENZYMATIC CO2 REAGENT, MODIFICATION (September 24, 1993)
  • K913225 — URINE/CSF MICROPROTEIN REAGENT (October 11, 1991)

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)

FDA data resources