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510(k) K904655

PYLORISET by Orion Diagnostica, Inc. — Product Code LYR

K904655 is an FDA 510(k) premarket notification submitted by Orion Diagnostica, Inc. for the device "PYLORISET". The FDA issued a decision of Substantially Equivalent on October 21, 1991. The device falls under product code LYR (Helicobacter Pylori), a Class I device regulated under 21 CFR 866.3110. Orion Diagnostica, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 1991
Date Received
October 12, 1990
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 Orion Diagnostica, Inc.

  • K142993 — QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, (March 10, 2016)
  • K043125 — ORION DIAGNOSTICA UNIQ PINP RIA (May 4, 2005)
  • K042625 — QUIKREAD CRP CALIBRATOR SET (November 18, 2004)
  • K042442 — QUICKREAD SYSTEM: QUICKREAD CRP KIT, MODEL 06085; QUICKREAD 101 INSTRUMENT, MODE (September 24, 2004)
  • K942286 — DIARLEX ROTA-ADENO (December 14, 1994)
  • K914892 — SALIVA-STIM (September 2, 1992)
  • K884074 — IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN G (October 27, 1988)
  • K884147 — IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN M (October 27, 1988)
  • K884040 — IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN A (October 19, 1988)
  • K884075 — IMMUNOCHEMICAL DETERMINATION OF TRANSFERRIN (October 19, 1988)

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