Device Classification Name |
enzyme linked immunoabsorbent assay, rubella
|
510(k) Number |
K861282 |
Device Name |
MUREX SUDS RUBELLA |
Applicant |
MUREX CORP. |
P.O. NOC 2003 |
NORCROSS,
GA
30091
|
|
Applicant Contact |
MARSHALL, PH.D |
Correspondent |
MUREX CORP. |
P.O. NOC 2003 |
NORCROSS,
GA
30091
|
|
Correspondent Contact |
MARSHALL, PH.D |
Regulation Number | 866.3510
|
Classification Product Code |
|
Date Received | 04/07/1986 |
Decision Date | 06/13/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|