Device Classification Name |
visual, pregnancy hcg, prescription use
|
510(k) Number |
K870521 |
Device Name |
TANDEM(R) M-PAK(TM) TOTAL B-HCG IMMUNOENZY. ASSAY |
Applicant |
HYBRITECH, INC. |
11095 TORREYANA RD. |
P.O. BOX 269006 |
SAN DIEGO,
CA
92126
|
|
Applicant Contact |
KABAKOFF, PHD |
Correspondent |
HYBRITECH, INC. |
11095 TORREYANA RD. |
P.O. BOX 269006 |
SAN DIEGO,
CA
92126
|
|
Correspondent Contact |
KABAKOFF, PHD |
Regulation Number | 862.1155
|
Classification Product Code |
|
Date Received | 02/06/1987 |
Decision Date | 04/08/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|