Chrysalis Intelligence · Sponsors · BD Diagnostic Systems

BD Diagnostic Systems

Sparks, MD, US · 1 510(k) clearances · 5 PMAs

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Total clearances

1

2026-05-28 → 2026-05-28

Last 12 months

1

Product codes

1

Most recent

2026-05-28

Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code	Device name	Class	Specialty	Clearances	Most recent
MDB	System, Blood Culturing	Class I	Microbiology	1	2026-05-28

Class III

PMA approvals (5)

Total PMA records

5

Originals + supplements

Distinct product codes

1

First decision

2021-02-16

Most recent

2024-09-06

Date	PMA #	Trade name	Type	Code	Device name	Specialty
2024-09-06	P970018-S041	BD PrepStain System, BD Totalys MultiProcessor, BD Totalys SlidePre, BD SurePath Liquid-based Pap Test	Special (Immediate Track)	MKQ	Processor, Cervical Cytology Slide, Automated	Unknown
2023-12-28	P970018-S040	BD PrepMate	Normal 180 Day Track No User Fee	MKQ	Processor, Cervical Cytology Slide, Automated	Unknown
2021-12-21	P970018-S039	BD Totalys MultiProcessor	Real-Time Process	MKQ	Processor, Cervical Cytology Slide, Automated	Unknown
2021-05-20	P970018-S038	BD PrepStain System	Real-Time Process	MKQ	Processor, Cervical Cytology Slide, Automated	Unknown
2021-02-16	P970018-S037	BD PrepStain System	30-Day Notice	MKQ	Processor, Cervical Cytology Slide, Automated	Unknown

Filings

All 510(k) clearances (1)

Date	K-number	Device	Code	Class	Specialty
2026-05-28	K260213	BD BACTEC FXI Culture System	MDB	Class I	Microbiology