Device Classification Name |
sulfophosphovanillin, colorimetry, total lipids
|
510(k) Number |
K820500 |
Device Name |
TOTAL LIPID REAGENT SET |
Applicant |
ANCO MEDICAL REAGENTS & ASSOC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
ANCO MEDICAL REAGENTS & ASSOC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 862.1470
|
Classification Product Code |
|
Date Received | 02/23/1982 |
Decision Date | 03/11/1982 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|