Device Classification Name |
dna-reagents, neisseria
|
510(k) Number |
K872628 |
Device Name |
GONOSPOT* DNA PROBE CULTURE CONFIRMATION TEST |
Applicant |
ORTHO DIAGNOSTIC SYSTEMS, INC. |
1001 U.S. HIGHWAY 202 |
P.O. BOX 350 |
RARITAN,
NJ
08869 -0606
|
|
Applicant Contact |
PATRICIA BONNESS |
Correspondent |
ORTHO DIAGNOSTIC SYSTEMS, INC. |
1001 U.S. HIGHWAY 202 |
P.O. BOX 350 |
RARITAN,
NJ
08869 -0606
|
|
Correspondent Contact |
PATRICIA BONNESS |
Regulation Number | 866.3390
|
Classification Product Code |
|
Date Received | 07/06/1987 |
Decision Date | 12/21/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|