Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K213379
Device Classification Name
Kit, Test, Pregnancy, Hcg, Over The Counter
More FDA Info for this Device
510(K) Number
K213379
Device Name
Kit, Test, Pregnancy, Hcg, Over The Counter
Applicant
SPD Swiss Precision Diagnostics GmbH
47 Route de Saint Georges, Petit-Lancy
Geneva CH-1213 CH
Other 510(k) Applications for this Company
Contact
Joanne Scaife
Other 510(k) Applications for this Contact
Regulation Number
862.1155
More FDA Info for this Regulation Number
Classification Product Code
LCX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/13/2021
Decision Date
09/21/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact