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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NamePREPSTAIN SYSTEM
Classification Nameprocessor, cervical cytology slide, automated
Generic Namecervical cytology slide preparation device
ApplicantBD DIAGNOSTIC SYSTEMS
PMA NumberP970018
Supplement NumberS012
Date Received04/19/2007
Decision Date05/09/2007
Product Code
MKQ[ Registered Establishments with MKQ ]
Advisory Committee Hematology
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for labeling changes for extension of the antimicrobial effectiveness of the surepath preservative fluid to 14 days for e. Coli, p. Aeruginosa, s. Aureus, c. Albicans, and a. Niger and 28 days for m. Tuberculosis.
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