Device Classification Name |
reagent, occult blood
|
510(k) Number |
K041202 |
Device Name |
HEMOSURE ONE-STEP FECAL OCCULT BLOOD TEST |
Applicant |
W.H.P.M., INC. |
163 CABOT ST. |
BEVERLY,
MA
01915
|
|
Applicant Contact |
FRAN WHITE |
Correspondent |
W.H.P.M., INC. |
163 CABOT ST. |
BEVERLY,
MA
01915
|
|
Correspondent Contact |
FRAN WHITE |
Regulation Number | 864.6550
|
Classification Product Code |
|
Date Received | 05/07/2004 |
Decision Date | 08/12/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|