Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K993837
Device Classification Name
Glucose Oxidase, Glucose
More FDA Info for this Device
510(K) Number
K993837
Device Name
Glucose Oxidase, Glucose
Applicant
AVL SCIENTIFIC CORP.
235 HEMBREE PARK DR.
ROSWELL, GA 30076 US
Other 510(k) Applications for this Company
Contact
RANDY BYRD
Other 510(k) Applications for this Contact
Regulation Number
862.1345
More FDA Info for this Regulation Number
Classification Product Code
CGA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/12/1999
Decision Date
12/16/1999
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