Device Classification Name |
Station, Pipetting And Diluting, For Clinical Use
|
510(k) Number |
K883749 |
Device Name |
PROBE(TM) MODELS 700 AND 1000 |
Applicant |
PACKARD INSTRUMENT CO., INC. |
2200 WARRENVILLE RD. |
DOWNERS GROVE,
IL
60515
|
|
Applicant Contact |
GEORGE L RUSSELL |
Correspondent |
PACKARD INSTRUMENT CO., INC. |
2200 WARRENVILLE RD. |
DOWNERS GROVE,
IL
60515
|
|
Correspondent Contact |
GEORGE L RUSSELL |
Regulation Number | 862.2750 |
Classification Product Code |
|
Date Received | 09/01/1988 |
Decision Date | 11/10/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|