Device Classification Name |
electrode, ion specific, sodium
|
510(k) Number |
K053110 |
Device Name |
I-STAT CHEM8 + CARTRIDGE |
Applicant |
I-STAT CORPORATION |
104 WINDSOR CENTER DRIVE |
EAST WINDSOR,
NJ
08520
|
|
Applicant Contact |
PAUL VANDERWERF |
Correspondent |
I-STAT CORPORATION |
104 WINDSOR CENTER DRIVE |
EAST WINDSOR,
NJ
08520
|
|
Correspondent Contact |
PAUL VANDERWERF |
Regulation Number | 862.1665
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 11/04/2005 |
Decision Date | 01/13/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|