CERVISTA HUMAN PAPILLOMA VIRUS (HPV) HIGH RISK (HR)

FDA premarket approval P080014/S010 · decided 2012-01-20

Approval details

PMA number

P080014

Supplement

S010

Supplement type

30-Day Notice

Supplement reason

Process Change - Manufacturer/Sterilizer/Packager/Supplier

Trade name

CERVISTA HUMAN PAPILLOMA VIRUS (HPV) HIGH RISK (HR)

Generic name

KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS

Applicant

Hologic, Inc.

Date received

2011-12-28

Decision date

2012-01-20

Days to decision

23 days

Decision code

OK30

Product code

MAQ

Advisory committee

Microbiology

Expedited review

No

Location

Marlborough, MA

Statement

CHANGE TO REPLACE QUALITY CONTROL TEST METHOD CONTROLS WITH NEW QUALITY CONTROL TEST METHOD CONTROLS FROM THE SAME SUPPLIER FOR INCOMING MATERIALS INSPECTION TESTING AND IN-PROCESS QUALITY CONTROL TESTING OF ACCESSORY KIT REAGENTS.

510(k) clearances by this applicant