Chrysalis Intelligence · Sponsors · Promega Corporation

Promega Corporation

Madison, WI, US · 1 510(k) clearances · 1 PMAs

Total clearances
1
2021-07-26 → 2021-07-26
Last 12 months
0
Product codes
1
Most recent
2021-07-26
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
PZJ Lynch Syndrome Test System Class II Immunology 1 2021-07-26
Class III

PMA approvals (1)

Total PMA records
1
Originals + supplements
Distinct product codes
1
First decision
2025-11-05
Most recent
2025-11-05
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2025-11-05 P240026 OncoMate® MSI Dx Analysis System Original SFL Nucleic Acid Based Assay, Microsatellite Instability Unknown
Filings

All 510(k) clearances (1)

Date K-number Device Code Class Specialty
2021-07-26 K200129 OncoMate MSI Dx Analysis System PZJ Class II Immunology