Device Classification Name |
Media And Components, Synthetic Cell And Tissue Culture
|
510(k) Number |
K882776 |
Device Name |
DULBECCO'S MODIFIED EAGLE'S MEDIUM, NO. 200-2014 |
Applicant |
J R SCIENTIFIC |
ONE HARTER AVE., SUITE B |
P.O. BOX 1937 |
WOODLAND,
CA
95695
|
|
Applicant Contact |
JAN C BAKER |
Correspondent |
J R SCIENTIFIC |
ONE HARTER AVE., SUITE B |
P.O. BOX 1937 |
WOODLAND,
CA
95695
|
|
Correspondent Contact |
JAN C BAKER |
Regulation Number | 864.2220 |
Classification Product Code |
|
Date Received | 07/05/1988 |
Decision Date | 07/19/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Pathology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|