Device Classification Name |
multi-analyte controls, all kinds (assayed)
|
510(k) Number |
K913687 |
Device Name |
CHEM-CHEX |
Applicant |
STRECK LABORATORIES, INC. |
14306 INDUSTRIAL RD. |
P.O. BOX 37625 |
OMAHA,
NE
68144
|
|
Applicant Contact |
ROBERT M LACHOWIEZ |
Correspondent |
STRECK LABORATORIES, INC. |
14306 INDUSTRIAL RD. |
P.O. BOX 37625 |
OMAHA,
NE
68144
|
|
Correspondent Contact |
ROBERT M LACHOWIEZ |
Regulation Number | 862.1660
|
Classification Product Code |
|
Date Received | 08/19/1991 |
Decision Date | 09/19/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|