Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K991795
Device Classification Name
Immunoassay Method, Troponin Subunit
More FDA Info for this Device
510(K) Number
K991795
Device Name
Immunoassay Method, Troponin Subunit
Applicant
DIAGNOSTIC PRODUCTS CORP.
5700 WEST 96TH ST.
LOS ANGELES, CA 90045-5597 US
Other 510(k) Applications for this Company
Contact
EDWARD M LEVINE
Other 510(k) Applications for this Contact
Regulation Number
862.1215
More FDA Info for this Regulation Number
Classification Product Code
MMI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/26/1999
Decision Date
06/09/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact