Device Classification Name |
5-amp-phosphate release (colorimetric test), 5'-nucleotidase
|
510(k) Number |
K812670 |
Device Name |
SANDARE FAST 340 PHOSPHORUS PROCEDURE |
Applicant |
SANDARE CHEMICAL CO., INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
SANDARE CHEMICAL CO., INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 862.1520
|
Classification Product Code |
|
Date Received | 09/21/1981 |
Decision Date | 10/02/1981 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|