Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K973100
Device Classification Name
Calibrator, Secondary
More FDA Info for this Device
510(K) Number
K973100
Device Name
Calibrator, Secondary
Applicant
DADE CHEMISTRY SYSTEMS, INC.
GLASGOW SITE
P.O. BOX 6101
NEWARK, DE 19714-6101 US
Other 510(k) Applications for this Company
Contact
REBECCA S AYASH
Other 510(k) Applications for this Contact
Regulation Number
862.1150
More FDA Info for this Regulation Number
Classification Product Code
JIT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/19/1997
Decision Date
09/29/1997
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