Device Classification Name |
Hexokinase, Glucose
|
510(k) Number |
K072018 |
Device Name |
BS-200 CHEMISTRY ANALYZER, MODE BS-200 |
Applicant |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
55 NORTHERN BLVD., SUITE 200 |
GREAT NECK,
NY
11021
|
|
Applicant Contact |
SUSAN D GOLDSTEIN-FALK |
Correspondent |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
55 NORTHERN BLVD., SUITE 200 |
GREAT NECK,
NY
11021
|
|
Correspondent Contact |
SUSAN D GOLDSTEIN-FALK |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 07/23/2007 |
Decision Date | 02/01/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|