Device Classification Name |
diazo colorimetry, bilirubin
|
510(k) Number |
K040391 |
Device Name |
TOTAL BILIRUBIN REAGENT SET |
Applicant |
POINTE SCIENTIFIC, INC. |
1025 JOHN A. PAPALAS DR. |
LINCOLN PARK,
MI
48146
|
|
Applicant Contact |
RON JAMISON |
Correspondent |
POINTE SCIENTIFIC, INC. |
1025 JOHN A. PAPALAS DR. |
LINCOLN PARK,
MI
48146
|
|
Correspondent Contact |
RON JAMISON |
Regulation Number | 862.1110
|
Classification Product Code |
|
Date Received | 02/17/2004 |
Decision Date | 06/02/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Statement |
Statement
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|