Device Classification Name |
counter, cell, automated (particle counter)
|
510(k) Number |
K152776 |
Device Name |
Glocyte Automated Cell Counter System |
Applicant |
Advanced Instruments, Inc. |
2 Technology Way |
Norwood,
MA
02062
|
|
Applicant Contact |
Robert Mello |
Correspondent |
Advanced Instruments, Inc. |
2 Technology Way |
Norwood,
MA
02062
|
|
Correspondent Contact |
Robert Mello |
Regulation Number | 864.5200
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/25/2015 |
Decision Date | 05/27/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|