Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K993536
Device Classification Name
Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase
More FDA Info for this Device
510(K) Number
K993536
Device Name
Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase
Applicant
BIO-RAD
4000 ALFRED NOBEL DR.
HERCULES, CA 94547-1803 US
Other 510(k) Applications for this Company
Contact
ELIZABETH TANG
Other 510(k) Applications for this Contact
Regulation Number
862.1315
More FDA Info for this Regulation Number
Classification Product Code
KQP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/19/1999
Decision Date
11/04/1999
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