510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K010858Substantially Equivalent

Velogene Genomic Identification Assay for Mrsa with One-Step Detection

Id Biomedical Corp., Bothell WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K010858 is the FDA 510(k) clearance record for VELOGENE GENOMIC IDENTIFICATION ASSAY FOR MRSA WITH ONE-STEP DETECTION, a class II device, cleared for Id Biomedical Corp. on under FDA product code MYI (System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies). FDA records list 3 510(k) clearances for Id Biomedical Corp., from to . As of , FDA records show no recalls naming K010858.

Clearance record

Decision date
Received
(63 days to decision)
Product code
MYI System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies
Regulation
21 CFR 866.1640
Device class
Class II
Review panel
Microbiology
Applicant
Id Biomedical Corp. 19204 N. Creek Pkway., Suite 100, Bothell WA
510(k) summary
Summary
Third party review
No

Clearances, product code MYI

Trailing 12 months

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

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