Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K955286
Device Classification Name
Glucose Oxidase, Glucose
More FDA Info for this Device
510(K) Number
K955286
Device Name
Glucose Oxidase, Glucose
Applicant
JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC.
100 INDIGO CREEK DR.
ROCHESTER, NY 14650-0882 US
Other 510(k) Applications for this Company
Contact
CHARLES C MORGANSON, JR.
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
11/16/1995
Decision Date
05/17/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact