Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K993715
Device Classification Name
Enzyme Controls (Assayed And Unassayed)
More FDA Info for this Device
510(K) Number
K993715
Device Name
Enzyme Controls (Assayed And Unassayed)
Applicant
SERACARE TECHNOLOGY
2170 WOODWARD ST.
AUSTIN, TX 78744-1832 US
Other 510(k) Applications for this Company
Contact
RUSTY SEWELL
Other 510(k) Applications for this Contact
Regulation Number
862.1660
More FDA Info for this Regulation Number
Classification Product Code
JJT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/03/1999
Decision Date
11/16/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
IM - Immunology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact