Devices · BD DIAGNOSTICS

AUTOPAP(R) 300 QC AUTOMATIC PAP SCREENER/QC SYSTEM

BD DIAGNOSTICS is listed for AUTOPAP(R) 300 QC AUTOMATIC PAP SCREENER/QC SYSTEM (P950009). The FDA list gives September 29, 1995 as the date of the final decision. The lead panel is Pathology, and the database link on the FDA list is the PMA pathway. openFDA describes product code NMN as “Instrument, Clip, Forming/Cutting, Reprocessed”: Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf). openFDA records decision code APPR for this submission. This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P950009

Official FDA database record

Date of final decision

September 29, 1995

Company on the FDA list

BD DIAGNOSTICS

Lead panel

Pathology

Primary product code

NMN

openFDA device name for the code

Instrument, Clip, Forming/Cutting, Reprocessed

Device class

1

Regulation number

882.4190

openFDA decision description

Not returned

openFDA decision code

APPR

Statement or summary label

Statement