THINPEP 2000 SYSTEM AND THINPREP 3000 PROCESSOR: PRESERVCYT SOLUTION, ALTERNATIVE TRANSPORT MEDIUM FOR ROCHE DIAGNOSTIC
FDA premarket approval P950039/S010 · decided 2003-03-27
Approval details
- PMA number
- P950039
- Supplement
- S010
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- THINPEP 2000 SYSTEM AND THINPREP 3000 PROCESSOR: PRESERVCYT SOLUTION, ALTERNATIVE TRANSPORT MEDIUM FOR ROCHE DIAGNOSTIC
- Generic name
- Processor, cervical cytology slide, automated
- Applicant
- Hologic, Inc.
- Date received
- 2003-02-19
- Decision date
- 2003-03-27
- Days to decision
- 36 days
- Decision code
- APPR
- Product code
- MKQ
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Malborough, MA
- Statement
- APPROVAL FOR LABELING CHANGES FOR THE PRESERVCYT SOLUTION AS AN ALTERNATIVE TRANSPORT MEDIUM FOR ROCHE DIAGNOSTICS COBAS AMPLICOR CT/NG TEST.
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