Device Classification Name |
analyzer, chemistry (photometric, discrete), for clinical use
|
510(k) Number |
K945566 |
Device Name |
ABBOTT PROJECT I, SPECTRUM |
Applicant |
ABBOTT LABORATORIES |
P.O. BOX 152020 |
1921 HURD DRIVE |
IRVING,
TX
75015 -2020
|
|
Applicant Contact |
Irene Powers |
Correspondent |
ABBOTT LABORATORIES |
P.O. BOX 152020 |
1921 HURD DRIVE |
IRVING,
TX
75015 -2020
|
|
Correspondent Contact |
Irene Powers |
Regulation Number | 862.2160
|
Classification Product Code |
|
Date Received | 10/21/1994 |
Decision Date | 06/09/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|