Device Classification Name |
Condom
|
510(k) Number |
K890819 |
Device Name |
HSV-CHECK(TM) TEST KIT |
Applicant |
DIAGNOSTIC TECHNOLOGY, INC. |
240 VANDERBILT MOTOR PKWY. |
HAUPPAUGE,
NY
11788
|
|
Applicant Contact |
ROBERT E LIND |
Correspondent |
DIAGNOSTIC TECHNOLOGY, INC. |
240 VANDERBILT MOTOR PKWY. |
HAUPPAUGE,
NY
11788
|
|
Correspondent Contact |
ROBERT E LIND |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 02/17/1989 |
Decision Date | 06/20/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Microbiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|