Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K092704
Device Classification Name
Dna-Reagents, Chlamydia
More FDA Info for this Device
510(K) Number
K092704
Device Name
Dna-Reagents, Chlamydia
Applicant
ABBOTT MOLECULAR, INC.
1300 EAST TOUHY AVENUE
DES PLAINES, IL 60018 US
Other 510(k) Applications for this Company
Contact
PAULA MARTIN
Other 510(k) Applications for this Contact
Regulation Number
866.3120
More FDA Info for this Regulation Number
Classification Product Code
LSK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/03/2009
Decision Date
05/28/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact