510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K101234Substantially Equivalent

Ventana Anti-Helicobacter Pylori (Sp48) Rabbit Monoclonal Primary Antibody

Ventana Medical Systems Inc, Tucson AZ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K101234 is the FDA 510(k) clearance record for VENTANA ANTI-HELICOBACTER PYLORI (SP48) RABBIT MONOCLONAL PRIMARY ANTIBODY, a class I device, cleared for Ventana Medical Systems, Inc. on under FDA product code OWF (Immunohistochemical Assay, Helicobacter Pylori). FDA's definition for product code OWF reads: "Anti-helicobacter pylori rabbit monoclonal primary antibody is designed to qualitatively detect the presence of helicobacter pylori in formalin-fixed, paraffin-embedded gastric biopsy tissue via light microscopy. Immunohistochemical...". FDA records list 49 510(k) clearances for Ventana Medical Systems, Inc., from to . As of , FDA records show one recall naming K101234.

Clearance record

Decision date
Received
(479 days to decision)
Product code
OWF Immunohistochemical Assay, Helicobacter Pylori
Regulation
21 CFR 866.3110
Device class
Class I
Review panel
Microbiology
Applicant
Ventana Medical Systems, Inc. 1910 E. Innovation Park Dr., Tucson AZ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OWF

Trailing 12 months

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

FDA records show no clearances under product code OWF in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OWF, 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