Device Classification Name |
Test, Time, Partial Thromboplastin
|
510(k) Number |
K921684 |
Device Name |
PTT-LA TEST KIT |
Applicant |
AMERICAN BIOPRODUCTS CO. |
601 NORTH JEFFERSON RD. |
PARSIPPANY,
NJ
07054
|
|
Applicant Contact |
LOC B LE |
Correspondent |
AMERICAN BIOPRODUCTS CO. |
601 NORTH JEFFERSON RD. |
PARSIPPANY,
NJ
07054
|
|
Correspondent Contact |
LOC B LE |
Regulation Number | 864.7925
|
Classification Product Code |
|
Date Received | 04/08/1992 |
Decision Date | 06/09/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|