Device Classification Name |
system, suspension, cell culture
|
510(k) Number |
K780305 |
Device Name |
CELL |
Applicant |
DYNATECH LABORATORIES, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
DYNATECH LABORATORIES, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 864.2240
|
Classification Product Code |
|
Date Received | 02/23/1978 |
Decision Date | 03/27/1978 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Pathology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|