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510(k) K960478

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

K960478 is an FDA 510(k) premarket notification submitted by Chemtrak, Inc. for the device "ACCUMETER H. PYLORI TEST". The FDA issued a decision of Substantially Equivalent on June 27, 1996. The device falls under product code LYR (Helicobacter Pylori), a Class I device regulated under 21 CFR 866.3110. Chemtrak, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 1996
Date Received
February 2, 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)
  • K965099 — ACCUMETER H. PYLORI TEST (February 20, 1997)
  • 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)

Other clearances for product code LYR

  • K232892 — Hp Detect™ Stool Antigen ELISA (December 15, 2023)
  • K230901 — Premier HpSA Flex (619096) (July 3, 2023)
  • K192817 — Curian HpSA, Curian Analyzer (March 13, 2020)
  • 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)
  • K181400 — H. PYLORI CHEK™ (August 21, 2018)
  • K181379 — H. PYLORI QUIK 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)

FDA data resources