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Monoprep Pap Test

by Hologic, Inc.

PMA P040052

Monoprep Pap Test is a Class III device made by Hologic, Inc., approved under FDA PMA P040052 on 3 Mar 2006, withdrawn as of 6 Oct 2026.

Withdrawn Withdrawn in United States.

Was authorized under PMA, withdrawn

Ended

Withdrawn 3 Mar 2006

PMA

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Source FDA PMA, synced 6 Oct 2026.

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPWD Approval withdrawn NumberP040052 Date3 Mar 2006Approval withdrawnStatusWithdrawn

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Withdrawn

Specification

PMA

Generic name
Processor, cervical cytology slide, automated
PMA number
FDA product code
MKQ
Device class
Class III
Advisory committee
Pathology
FDA decision
APWD Approval withdrawn

Similar devices

Other devices filed under FDA product code MKQ (Processor, Cervical Cytology Slide, Automated).

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