Device Classification Name |
System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
|
510(k) Number |
K093346 |
Device Name |
BD GENEOHM MRSA ACP ASSAY |
Applicant |
BD DIAGNOSTICS (GENEOHM SCIENCES, INC.) |
6146 NANCY RIDGE DR. |
SAN DIEGO,
CA
92121
|
|
Applicant Contact |
RAYMOND BOULE |
Correspondent |
BD DIAGNOSTICS (GENEOHM SCIENCES, INC.) |
6146 NANCY RIDGE DR. |
SAN DIEGO,
CA
92121
|
|
Correspondent Contact |
RAYMOND BOULE |
Regulation Number | 866.1640
|
Classification Product Code |
|
Date Received | 10/26/2009 |
Decision Date | 12/15/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|