Device Classification Name |
radioassay, intrinsic factor blocking antibody
|
510(k) Number |
K033603 |
Device Name |
INSTRINSIC FACTOR AB, CALIBRATORS, AND QC ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 387992, 387993, 387999 |
Applicant |
BECKMAN COULTER, INC. |
1000 LAKE HAZELTINE DR. |
CHASKA,
MN
55318 -1084
|
|
Applicant Contact |
VALYNDA MACHEN |
Correspondent |
BECKMAN COULTER, INC. |
1000 LAKE HAZELTINE DR. |
CHASKA,
MN
55318 -1084
|
|
Correspondent Contact |
VALYNDA MACHEN |
Regulation Number | 862.1810
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 11/17/2003 |
Decision Date | 12/19/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|