510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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MKQClass III

Processor, Cervical Cytology Slide, Automated

Unknown
FDA source (opens on fda.gov)

MKQ is the FDA product code for Processor, Cervical Cytology Slide, Automated, a class III device type. FDA's definition for this code reads: "It is a system that is used to collect and prepare cervical cytology specimens for Pap stain-based screening for cervical cancer. The specimens are collected and rinsed into a liquid preservative fluid from which they are then automatically filtered and deposited in a thin-layer on a glass microscope slide. They are...". As of , FDA records hold no 510(k) clearances under this code and 29 recalls.

Classification record

Product code
MKQ
Device name
Processor, Cervical Cytology Slide, Automated
FDA definition
It is a system that is used to collect and prepare cervical cytology specimens for Pap stain-based screening for cervical cancer. The specimens are collected and rinsed into a liquid preservative fluid from which they are then automatically filtered and deposited in a thin-layer on a glass microscope slide. They are stained and screened by a cytotechnologist and cytopathologist.
Device class
Class III
Review panel
Unknown
Submission type
PMA
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
29

Companies listing this code with FDA

Companies whose registered establishments list this code