Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K972720
Device Classification Name
Radioimmunoassay, Follicle-Stimulating Hormone
More FDA Info for this Device
510(K) Number
K972720
Device Name
Radioimmunoassay, Follicle-Stimulating Hormone
Applicant
MONOBIND
729 WEST 16TH ST., C-4
COSTA MESA, CA 92627 US
Other 510(k) Applications for this Company
Contact
FREDERICK R JEROME
Other 510(k) Applications for this Contact
Regulation Number
862.1300
More FDA Info for this Regulation Number
Classification Product Code
CGJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/21/1997
Decision Date
09/02/1997
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