Device Classification Name |
Radioimmunoassay, Parathyroid Hormone
|
510(k) Number |
K004038 |
Device Name |
TOTAL PTH IMMUNORADIOMETRIC ASSAY(IRMA) DIAGNOSTIC KIT, MODEL 3KG600 |
Applicant |
SCANTIBODIES LABORATORY, INC. |
9336 ABRAHAM WAY |
SANTEE,
CA
92071
|
|
Applicant Contact |
RICHARD LENART |
Correspondent |
SCANTIBODIES LABORATORY, INC. |
9336 ABRAHAM WAY |
SANTEE,
CA
92071
|
|
Correspondent Contact |
RICHARD LENART |
Regulation Number | 862.1545
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/28/2000 |
Decision Date | 04/30/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|