Device Classification Name |
Electrode, Ion Based, Enzymatic, Creatinine
|
510(k) Number |
K973292 |
Device Name |
I-STAT SYSTEM |
Applicant |
I-STAT CORP. |
303 COLLEGE RD. EAST |
PRINCETON,
NJ
08540
|
|
Applicant Contact |
IMANTS R LAUKS |
Correspondent |
I-STAT CORP. |
303 COLLEGE RD. EAST |
PRINCETON,
NJ
08540
|
|
Correspondent Contact |
IMANTS R LAUKS |
Regulation Number | 862.1225
|
Classification Product Code |
|
Date Received | 09/02/1997 |
Decision Date | 10/20/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|