Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K140801
Device Classification Name
Assay, Glycosylated Hemoglobin
More FDA Info for this Device
510(K) Number
K140801
Device Name
Assay, Glycosylated Hemoglobin
Applicant
BIO-RAD LABORATORIES, INC.
4000 ALFRED NOBEL DR.
HERCULES, CA 94547 US
Other 510(k) Applications for this Company
Contact
EBONY MCKINNIES
Other 510(k) Applications for this Contact
Regulation Number
864.7470
More FDA Info for this Regulation Number
Classification Product Code
LCP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/31/2014
Decision Date
06/25/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
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