Device Classification Name |
Hydrazone Colorimetry, Alt/Sgpt
|
510(k) Number |
K991834 |
Device Name |
CHOLESTECH LDX ALANINE AMINOTRANSFERASE (ALT), MODEL 11-772 |
Applicant |
CHOLESTECH CORP. |
3347 INVESTMENT BLVD. |
HAYWARD,
CA
94545
|
|
Applicant Contact |
THOMAS E WORTHY |
Correspondent |
CHOLESTECH CORP. |
3347 INVESTMENT BLVD. |
HAYWARD,
CA
94545
|
|
Correspondent Contact |
THOMAS E WORTHY |
Regulation Number | 862.1030
|
Classification Product Code |
|
Date Received | 05/28/1999 |
Decision Date | 09/09/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|