Device Classification Name |
calibrator, multi-analyte mixture
|
510(k) Number |
K897177 |
Device Name |
CALIBRATORS, CONTROL MATERIALS, ELECTRODES & TUBE |
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 | 862.1150
|
Classification Product Code |
|
Date Received | 12/27/1989 |
Decision Date | 03/27/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|