Device Classification Name |
calibrators, drug mixture
|
510(k) Number |
K843507 |
Device Name |
EMIT 700 CALIBRATOR B |
Applicant |
SYVA CO. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
SYVA CO. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 862.3200
|
Classification Product Code |
|
Date Received | 09/06/1984 |
Decision Date | 09/26/1984 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Toxicology
|
510k Review Panel |
Toxicology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|