Device Classification Name |
Visual, Pregnancy Hcg, Prescription Use
|
510(k) Number |
K842633 |
Device Name |
TANDEM FAST VISUAL HCG ASSAY KIT - |
Applicant |
HYBRITECH, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
HYBRITECH, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 862.1155
|
Classification Product Code |
|
Date Received | 07/09/1984 |
Decision Date | 08/23/1984 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|