Device Classification Name |
Calibrator, Multi-Analyte Mixture
|
510(k) Number |
K981706 |
Device Name |
AMM CAL, BIL CAL, CO2 CAL, HDL CAL, IRON/MG CAL, LDL CAL, MC CAL, UPRO CAL, AND ISE CALIBRATOR LEVELS 1 AND 2 |
Applicant |
ABBOTT LABORATORIES |
1920 HURD DR. |
IRVING,
TX
75038
|
|
Applicant Contact |
MARK LITTLEFIELD |
Correspondent |
ABBOTT LABORATORIES |
1920 HURD DR. |
IRVING,
TX
75038
|
|
Correspondent Contact |
MARK LITTLEFIELD |
Regulation Number | 862.1150
|
Classification Product Code |
|
Date Received | 05/14/1998 |
Decision Date | 07/09/1998 |
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
|
Recalls |
CDRH Recalls
|
|
|