Chrysalis Intelligence · Sponsors · Gen-Probe

Gen-Probe

0 510(k) clearances · 2 PMAs

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Total clearances

0

None → None

Last 12 months

0

Product codes

0

Most recent

—

Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code	Device name	Class	Specialty	Clearances	Most recent

Class III

PMA approvals (2)

Total PMA records

2

Originals + supplements

Distinct product codes

1

First decision

2020-02-14

Most recent

2020-07-21

Date	PMA #	Trade name	Type	Code	Device name	Specialty
2020-07-21	P020011-S016	Aptima HCV RNA Qualitative Assay	30-Day Notice	MZP	—	—
2020-02-14	P020011-S015	Aptima HCV RNA Qualitative Assay	30-Day Notice	MZP	—	—

Filings

510(k) clearances (none indexed)

Date	K-number	Device	Code	Class	Specialty