O N Diagnostics L L C

FDA Filings

This page includes the latest FDA filings for O N Diagnostics L L C. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3010687441
• FEI Number: 3010687441
• Name: O.N. DIAGNOSTICS, LLC
• Owner & Operator: O.N. Diagnostics, LLC
• Contact Address: 2150 Shattuck Ave. Suite 610 ; Berkeley CA 94704 US
• Official Correspondent:
  • Shui Wong
  • x-510-9135751-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 2150 Shattuck Ave. Suite 610 ; Berkeley, CA 94704 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 00860000233118 O N DIAGNOSTICS LLC	VirtuOst VFA	2019-10-07
GUDID 00860000233101 O N DIAGNOSTICS LLC	VirtuOst	2019-10-07
PMN K171435 | LLZ O.N. DIAGNOSTICS, LLC	VirtuOst Vertebral Fracture Assessment	2018-08-09
PMN K171435 O.N. Diagnostics, LLC.	VirtuOst Vertebral Fracture Assessment	2018-08-03
PMN K113725 | KGI O.N. DIAGNOSTICS, LLC	VirtuOst	2014-01-16
PMN K113725 | KGI O.N. DIAGNOSTICS, LLC	VirtuOst Bone Strength Assessment	2014-01-16
PMN K113725 | JAK O.N. DIAGNOSTICS, LLC	VirtuOst	2014-01-16
PMN K113725 | JAK O.N. DIAGNOSTICS, LLC	VirtuOst Bone Strength Assessment	2014-01-16

Similar & Related FDA Registered Companies

• Ortho-Clinical Diagnostics, Inc.100 Indigo Creek Dr.rochester, NY 14626-5101 PMA NumberP030026 Supplement NumberS037 Date Received09/30/2022 Decision Date01/24/2023 Product Code LOM  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
• Ortho-Clinical Diagnostics, Inc.100 Indigo Creek Dr.rochester, NY 14626-5101 PMA NumberP090028 Supplement NumberS018 Date Received09/30/2022 Decision Date01/24/2023 Product Code LOM  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
• ORTHO-CLINICAL DIAGNOSTICS100 Indigo Creek Dr.rochester, NY 14626-5101 PMA NumberP100001 Supplement NumberS017 Date Received09/30/2022 Decision Date01/24/2023 Product Code LOM  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
• ORIGIN DIAGNOSTICS LLC

Related Finance Registrations

NCAGE Code	4GC29	O N DIAGNOSTICS LLC
CAGE Code	4GC29	O N DIAGNOSTICS LLC
S.A.M. Registration	4GC29 [145086513]	O N DIAGNOSTICS LLC
DUNS	145086513	O N Diagnostics LLC