| Device Classification Name |
System, Test, Human Chorionic Gonadotropin
|
|---|
| 510(k) Number |
K974425 |
|---|
| Device Name |
BIOSIGN HCG-ONE STEP PREGNANCY TEST, ACCUSIGN HCG-ONE STEP PREGNANCY TEST, LIFESIGN HCG-ONE STEP PREGNANCY TEST |
|---|
| Applicant |
| Princeton BioMeditech Corp. |
| 4242 U.S. Rt. 1 |
|
Monmouth Junction,
NJ
08852
|
|
| Applicant Contact |
JEMO KANG |
| Correspondent |
| Princeton BioMeditech Corp. |
| 4242 U.S. Rt. 1 |
|
Monmouth Junction,
NJ
08852
|
|
| Correspondent Contact |
JEMO KANG |
| Regulation Number | 862.1155 |
|---|
| Classification Product Code |
|
|---|
| Date Received | 11/24/1997 |
|---|
| Decision Date | 12/24/1997 |
|---|
| Decision |
Substantially Equivalent
(SESE) |
|---|
| Regulation Medical Specialty |
Clinical Chemistry
|
|---|
| 510k Review Panel |
Clinical Chemistry
|
|---|
| Statement |
Statement
|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Combination Product |
No
|
|---|
Predetermined Change
Control Plan Authorized |
No
|
|---|