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510(k) K080851

A/C PORTABLE ENZYMATIC HOMOCYSTEINE ASSAY by Anticancer, Inc. — Product Code LPS

K080851 is an FDA 510(k) premarket notification submitted by Anticancer, Inc. for the device "A/C PORTABLE ENZYMATIC HOMOCYSTEINE ASSAY". The FDA issued a decision of Substantially Equivalent on October 10, 2008. The device falls under product code LPS (Urinary Homocystine (Nonquantitative) Test System), a Class II device regulated under 21 CFR 862.1377. Anticancer, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 2008
Date Received
March 26, 2008
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 Anticancer, Inc.

  • K111260 — A/C ENZYMATIC VITAMIN B6 ASSAY (July 26, 2012)
  • K030754 — A/C ENZYMATIC HOMOCYSTEINE ASSAY (July 11, 2003)

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)
  • 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)
  • K063206 — DIMENSION VISTA HCYS FLEX REAGENT CARTRIDGE; PROTEIN 1 CALIBRATOR; PROTEIN 1 CON (December 28, 2006)

FDA data resources