Device Classification Name |
Electrode, Ion Specific, Sodium
|
510(k) Number |
K001154 |
Device Name |
I-STAT MODEL 200 PORTABLE CLINICAL ANALYZER |
Applicant |
I-STAT CORP. |
104 WINDSOR CENTER DR. |
EAST WINDSOR,
NJ
08520
|
|
Applicant Contact |
PAUL VANDERWERF |
Correspondent |
I-STAT CORP. |
104 WINDSOR CENTER DR. |
EAST WINDSOR,
NJ
08520
|
|
Correspondent Contact |
PAUL VANDERWERF |
Regulation Number | 862.1665 |
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 04/10/2000 |
Decision Date | 04/18/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
Recalls |
CDRH Recalls
|