Device Classification Name |
extractable antinuclear antibody, antigen and control
|
510(k) Number |
K881181 |
Device Name |
NOVA GEL(TM) SM/RNP |
Applicant |
INOVA DIAGNOSTICS, INC. |
10451 ROSELLE ST. |
SAN DIEGO,
CA
92121
|
|
Applicant Contact |
BRYS C MYERS |
Correspondent |
INOVA DIAGNOSTICS, INC. |
10451 ROSELLE ST. |
SAN DIEGO,
CA
92121
|
|
Correspondent Contact |
BRYS C MYERS |
Regulation Number | 866.5100
|
Classification Product Code |
|
Date Received | 03/02/1988 |
Decision Date | 04/06/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Immunology
|
510k Review Panel |
Immunology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|