|
Device | AUTOPAP(R) 300 QC AUTOMATIC PAP SCREENER/QC SYSTEM |
Generic Name | READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED |
Applicant | BD DIAGNOSTICS 4025 STIRRUP CREEK DRIVE SUITE 400 DURHAM, NC 27703 |
PMA Number | P950009 |
Supplement Number | S001 |
Date Received | 11/06/1995 |
Decision Date | 04/25/1996 |
Product Code |
MNM |
Advisory Committee |
Pathology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR CHANGES MADE TO THE MANUAL TO IMPROVE HOW THE REPORT FORMS WILL LOOK, FOR CLARITY. |