510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K971537Substantially Equivalent

Pyloriset Eia-G (68926)

Orion Diagnostica, Div. Orion Corp., Espoo, FI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K971537 is the FDA 510(k) clearance record for PYLORISET EIA-G (68926), a class I device, cleared for Orion Diagnostica, Div. Orion Corp. on under FDA product code LYR (Helicobacter Pylori). FDA records list 4 510(k) clearances for Orion Diagnostica, Div. Orion Corp., from to . As of , FDA records show no recalls naming K971537.

Clearance record

Decision date
Received
(60 days to decision)
Product code
LYR Helicobacter Pylori
Regulation
21 CFR 866.3110
Device class
Class I
Review panel
Microbiology
Applicant
Orion Diagnostica, Div. Orion Corp. Koivumankkaantie 6, Espoo, FI
510(k) summary
Statement
Third party review
No

Clearances, product code LYR

Trailing 12 months

FDA records hold no clearances under product code LYR in the trailing twelve months.

FDA records show no clearances under product code LYR in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LYR, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260