Device Classification Name |
Calibrators, Drug Mixture
|
510(k) Number |
K902578 |
Device Name |
EMIT(R) II CALIBRATOR A LEVEL 1 & LEVEL 2 |
Applicant |
SYVA CO. |
900 ARASTRADERO RD. |
P.O. BOX 10058 |
PALO ALTO,
CA
94303
|
|
Applicant Contact |
ROGERS, JR. |
Correspondent |
SYVA CO. |
900 ARASTRADERO RD. |
P.O. BOX 10058 |
PALO ALTO,
CA
94303
|
|
Correspondent Contact |
ROGERS, JR. |
Regulation Number | 862.3200
|
Classification Product Code |
|
Date Received | 06/11/1990 |
Decision Date | 07/10/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Toxicology
|
510k Review Panel |
Toxicology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|