Device Classification Name |
counter, cell, automated (particle counter)
|
510(k) Number |
K812031 |
Device Name |
LPC II |
Applicant |
LABTRONIX CORP. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
LABTRONIX CORP. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 864.5200
|
Classification Product Code |
|
Date Received | 07/20/1981 |
Decision Date | 08/12/1981 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|