Device Classification Name |
Calibrator For Hemoglobin And Hematocrit Measurement
|
510(k) Number |
K840261 |
Device Name |
CAL-CHEX, A HEMATOLOGY CALIBRATOR |
Applicant |
STRECK LABORATORIES, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
STRECK LABORATORIES, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 864.8165 |
Classification Product Code |
|
Date Received | 01/05/1984 |
Decision Date | 02/21/1984 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|