Device Classification Name |
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
|
510(k) Number |
K940289 |
Device Name |
ABBOTT PRISM ANALYZER |
Applicant |
ABBOTT MFG., INC. |
1921 HURD DR. |
IRVING,
TX
75038
|
|
Applicant Contact |
KATHY ZENG |
Correspondent |
ABBOTT MFG., INC. |
1921 HURD DR. |
IRVING,
TX
75038
|
|
Correspondent Contact |
KATHY ZENG |
Regulation Number | 862.2160
|
Classification Product Code |
|
Date Received | 03/02/1994 |
Decision Date | 07/18/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|