Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K193041
Device Classification Name
System, Multipurpose For In Vitro Coagulation Studies
More FDA Info for this Device
510(K) Number
K193041
Device Name
System, Multipurpose For In Vitro Coagulation Studies
Applicant
Accriva Diagnostics, Inc.
6260 Sequence Drive
San Diego, CA 92121 US
Other 510(k) Applications for this Company
Contact
Brian James
Other 510(k) Applications for this Contact
Regulation Number
864.5425
More FDA Info for this Regulation Number
Classification Product Code
JPA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/31/2019
Decision Date
11/22/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
HE - Hematology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact