Device Classification Name |
Lipase-Esterase, Enzymatic, Photometric, Lipase
|
510(k) Number |
K900827 |
Device Name |
COLORIMETRIC CHLORIDE PRODUCT #4314125 |
Applicant |
AMERICAN RESEARCH PRODUCTS CO. |
30175 SOLON INDUSTRIAL PKWY. |
P.O. BOX 39098 |
SOLON,
OH
44139
|
|
Applicant Contact |
C. K OWENS |
Correspondent |
AMERICAN RESEARCH PRODUCTS CO. |
30175 SOLON INDUSTRIAL PKWY. |
P.O. BOX 39098 |
SOLON,
OH
44139
|
|
Correspondent Contact |
C. K OWENS |
Regulation Number | 862.1465 |
Classification Product Code |
|
Date Received | 02/21/1990 |
Decision Date | 05/02/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|