Device Classification Name |
Kit, Test, Pregnancy, Hcg, Over The Counter
|
510(k) Number |
K032661 |
Device Name |
ACON QUICK-CHECK II HOME PREGNANCY TEST DEVICE (CASSETTE) |
Applicant |
ACON LABORATORIES, INC. |
4108 SORRENTO VALLEY BLVD. |
SAN DIEGO,
CA
92121
|
|
Applicant Contact |
EDWARD TUNG |
Correspondent |
ACON LABORATORIES, INC. |
4108 SORRENTO VALLEY BLVD. |
SAN DIEGO,
CA
92121
|
|
Correspondent Contact |
EDWARD TUNG |
Regulation Number | 862.1155
|
Classification Product Code |
|
Date Received | 08/28/2003 |
Decision Date | 10/14/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|