Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K973629
Device Classification Name
Multi-Analyte Controls, All Kinds (Assayed)
More FDA Info for this Device
510(K) Number
K973629
Device Name
Multi-Analyte Controls, All Kinds (Assayed)
Applicant
BOEHRINGER MANNHEIM CORP.
4300 HACIENDA DR.
PLEASANTON, CA 94588-2722 US
Other 510(k) Applications for this Company
Contact
YVETTE R LLOYD
Other 510(k) Applications for this Contact
Regulation Number
862.1660
More FDA Info for this Regulation Number
Classification Product Code
JJY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/24/1997
Decision Date
10/07/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
IM - Immunology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact