Atlas FDA

THINPREP(R) PROCESSOR, MODEL TP 2000

FDA premarket approval P950039 · decided 1996-05-20

Approval details

PMA number
P950039
Trade name
THINPREP(R) PROCESSOR, MODEL TP 2000
Generic name
Processor, cervical cytology slide, automated
Applicant
Hologic, Inc.
Date received
1995-11-22
Decision date
1996-05-20
Days to decision
180 days
Decision code
APPR
Product code
MKQ
Advisory committee
Pathology
Expedited review
No
Location
Malborough, MA
Statement
APPROVAL FOR THE THINPREP 2000 SYSTEM

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510(k) clearances by this applicant

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