Reader, Cervical Cytology Slide, Automated

Device Code: 5035

Product Code(s): MNM

Device Classification Information

• Device Type ID: 5035
• Device Name: Reader, Cervical Cytology Slide, Automated
• Review Panel: Pathology
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: PMA
• FDA Device Classification: Class 3 Medical Device
• Product Code: MNM
• GMP Exempt: No
• Summary MR: Ineligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

• Device Type ID: 5035
• Device: Reader, Cervical Cytology Slide, Automated
• Product Code: MNM
• FDA Device Classification: Class 3 Medical Device

Device Problems
Adverse Event Without Identified Device Or Use Problem	2
Date/Time-Related Software Problem	1
Total Device Problems	3

Recalls
Manufacturer		Recall Class	Date Posted
1	Becton Dickinson & Co.	III	Oct-05-2018

TPLC Last Update: 2019-04-02 20:59:09