Device Classification Name |
Calibrator, Multi-Analyte Mixture
|
510(k) Number |
K914909 |
Device Name |
IL TEST(TM) CALIBRATION SET SP |
Applicant |
INSTRUMENTATION LABORATORY CO. |
113 HARTWELL AVE. |
P.O. BOX 9113 |
LEXINGTON,
MA
02173
|
|
Applicant Contact |
GEORGE A LYNA |
Correspondent |
INSTRUMENTATION LABORATORY CO. |
113 HARTWELL AVE. |
P.O. BOX 9113 |
LEXINGTON,
MA
02173
|
|
Correspondent Contact |
GEORGE A LYNA |
Regulation Number | 862.1150
|
Classification Product Code |
|
Date Received | 11/01/1991 |
Decision Date | 01/22/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|