Device Classification Name |
Albumin, Fitc, Antigen, Antiserum, Control
More FDA Info for this Device |
510(K) Number |
K023860 |
Device Name |
Albumin, Fitc, Antigen, Antiserum, Control |
Applicant |
POINTE SCIENTIFIC, INC.
1025 JOHN A. PAPALAS DR.
LINCOLN PARK, MI 48146 US
Other 510(k) Applications for this Company
|
Contact |
RON JAMISON
Other 510(k) Applications for this Contact |
Regulation Number |
866.5040
More FDA Info for this Regulation Number |
Classification Product Code |
DDZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
11/20/2002 |
Decision Date |
04/28/2003 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
IM - Immunology |
Review Advisory Committee |
CH - Clinical Chemistry |
Statement / Summary / Purged Status |
Statement |
Type |
Traditional |
Reviewed By Third Party |
N |
Expedited Review |
|