Device Classification Name |
acid, lactic, enzymatic method
|
510(k) Number |
K100602 |
Device Name |
NOVA STATSTRIP LACTATE HOSPITAL METER, NOVA STATSTRIP LACTATE TEST STRIPS |
Applicant |
NOVA BIOMEDICAL CORP. |
200 PROSPECT ST. |
WALTHAM,
MA
02454 -9141
|
|
Applicant Contact |
PAUL W MACDONALD |
Correspondent |
NOVA BIOMEDICAL CORP. |
200 PROSPECT ST. |
WALTHAM,
MA
02454 -9141
|
|
Correspondent Contact |
PAUL W MACDONALD |
Regulation Number | 862.1450
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/03/2010 |
Decision Date | 08/17/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|