Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K971276
Device Classification Name
Hexokinase, Glucose
More FDA Info for this Device
510(K) Number
K971276
Device Name
Hexokinase, Glucose
Applicant
BAYER CORP.
1884 MILES AVE.
P.O. BOX 70
ELKHART, IN 46515-0070 US
Other 510(k) Applications for this Company
Contact
ROSANNE M SAVOL
Other 510(k) Applications for this Contact
Regulation Number
862.1345
More FDA Info for this Regulation Number
Classification Product Code
CFR
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/07/1997
Decision Date
06/16/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact