510(k) Premarket Notification Database
Device Classification Name |
hexokinase, glucose
|
510(k) Number | K984574 |
Device Name | INFINITY GLUCOSE REAGENT |
Applicant |
SIGMA DIAGNOSTICS, INC.
|
545 south ewing ave. |
st. louis,
MO
63103 |
|
Contact | william r gilbert |
Regulation Number | 862.1345 |
Classification Product Code |
|
Date Received | 12/23/1998 |
Decision Date | 02/11/1999 |
Decision |
substantially equivalent (SE) |
Classification Advisory Committee |
Clinical Chemistry
|
Review Advisory Committee |
Clinical Chemistry
|
Statement/Summary/Purged Status |
Summary only
|
summary |
summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Expedited Review |
No
|
|
|