Device Classification Name |
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
|
510(k) Number |
K974779 |
Device Name |
ABBOTT ALCYON(TM) 300 (WITHOUT ISE MODULE) AND 300I (WITH ISE MODULE) ANALYZER |
Applicant |
ABBOTT LABORATORIES |
1920 HURD DR. |
IRVING,
TX
75038
|
|
Applicant Contact |
ANDREW JOHNSON |
Correspondent |
ABBOTT LABORATORIES |
1920 HURD DR. |
IRVING,
TX
75038
|
|
Correspondent Contact |
ANDREW JOHNSON |
Regulation Number | 862.2160
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/22/1997 |
Decision Date | 02/13/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|