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510(k) K965099

ACCUMETER H. PYLORI TEST by Chemtrak, Inc. — Product Code LYR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 20, 1997
Date Received
December 20, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Helicobacter Pylori
Device Class
Class I
Regulation Number
866.3110
Review Panel
MI
Submission Type

Other clearances by Chemtrak, Inc.

  • K972495 — ACCUMETER THEOPHYLLINE TEST (October 10, 1997)
  • K960478 — ACCUMETER H. PYLORI TEST (June 27, 1996)
  • K943279 — ACCUMETER HDL CHOLESTEROL TEST (May 1, 1995)
  • K943599 — CHEM TRAK ACCUMETER (March 21, 1995)
  • K914432 — ACCUMETER(R) CHOLESTEROL SELF-TEST (March 2, 1993)
  • K905405 — CHEMTRAK ACCUMETER CHOLESTEROL TEST (March 19, 1991)

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  • K183573 — Vstrip H. pylori Antigen Rapid Test (March 14, 2019)
  • K182559 — PREMIER Platinum HpSA PLUS (November 5, 2018)
  • K181464 — LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set (August 31, 2018)
  • K181379 — H. PYLORI QUIK CHEK (August 21, 2018)
  • K181400 — H. PYLORI CHEK™ (August 21, 2018)
  • K161139 — LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set (July 22, 2016)
  • K153661 — ImmunoCard STAT! HpSA (March 14, 2016)