Device Classification Name |
Controls For Blood-Gases, (Assayed And Unassayed)
|
510(k) Number |
K935515 |
Device Name |
MULTICHECK(TM) |
Applicant |
RADIOMETER AMERICA, INC. |
811 SHARON DR. |
WESTLAKE,
OH
44145 -1598
|
|
Applicant Contact |
DONALD L BAKER |
Correspondent |
RADIOMETER AMERICA, INC. |
811 SHARON DR. |
WESTLAKE,
OH
44145 -1598
|
|
Correspondent Contact |
DONALD L BAKER |
Regulation Number | 862.1660
|
Classification Product Code |
|
Date Received | 11/15/1993 |
Decision Date | 04/26/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|