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510(k) K964675

H.PYLORI CONTROLS by Pyramid Biological Corp. — Product Code LYR

K964675 is an FDA 510(k) premarket notification submitted by Pyramid Biological Corp. for the device "H.PYLORI CONTROLS". The FDA issued a decision of Substantially Equivalent on January 27, 1997. The device falls under product code LYR (Helicobacter Pylori), a Class I device regulated under 21 CFR 866.3110. Pyramid Biological Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 1997
Date Received
November 21, 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 Pyramid Biological Corp.

  • K962399 — HEPATITIS NEGATIVE CONTROL (August 2, 1996)
  • K961317 — SYPHILIS IGM HUMAN SERUM CONTROLS (June 24, 1996)
  • K960493 — SYPHILIS IGG HUMAN SERUM CONTROLS (June 17, 1996)
  • K954515 — ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA (December 20, 1995)
  • K953826 — ENZYME LINKED UMMINOABSORBENT ASSAY, RUBELLA (December 14, 1995)
  • K952818 — ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII (November 20, 1995)
  • K952254 — ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS (November 16, 1995)
  • K951800 — CMV IGG HUMAN SERUM CONTROLS (November 16, 1995)
  • K944515 — SERUM PROTEIN CONTROLS (November 17, 1994)
  • K933218 — REFRACTOMETRIC, TOTAL PROTEIN (February 17, 1994)

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