PMA P970018S012

Device: PREPSTAIN SYSTEM
Applicant: Bd Diagnostic Systems
PMA number: P970018
Supplement: S012
Product code: MKQ
Decision date: 2007-05-09
Generic name: Processor, cervical cytology slide, automated
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.

Current openFDA PMA Record#

Device: PREPSTAIN SYSTEM
Applicant: Bd Diagnostic Systems
PMA number: P970018
Supplement: S012
Product code: MKQ
Generic name: Processor, cervical cytology slide, automated
Decision date: 2007-05-09
Decision code: APPR
Date received: 2007-04-19
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
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.