Device Classification Name |
Assay, Porphyrin, Spectrophotometry, Lithium
|
510(k) Number |
K003583 |
Device Name |
LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901 |
Applicant |
TRACE AMERICA, INC. |
845 AVE. G EAST |
ARLINGTON,
TX
76011
|
|
Applicant Contact |
THOMAS DOLLAR |
Correspondent |
TRACE AMERICA, INC. |
845 AVE. G EAST |
ARLINGTON,
TX
76011
|
|
Correspondent Contact |
THOMAS DOLLAR |
Regulation Number | 862.3560
|
Classification Product Code |
|
Date Received | 11/20/2000 |
Decision Date | 01/17/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Toxicology
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|