Device Classification Name |
System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
|
510(k) Number |
K033415 |
Device Name |
IDI-MRSA |
Applicant |
INFECTIO DIAGNOSTIC (I.D.I.) INC. |
2050 BOUL RENE-LEVESQUE O |
4 IEME ETAGE |
SAINTE-FOY,
CA
G1V 2K8
|
|
Applicant Contact |
CHRISTIAN CHOQUET |
Correspondent |
INFECTIO DIAGNOSTIC (I.D.I.) INC. |
2050 BOUL RENE-LEVESQUE O |
4 IEME ETAGE |
SAINTE-FOY,
CA
G1V 2K8
|
|
Correspondent Contact |
CHRISTIAN CHOQUET |
Regulation Number | 866.1640
|
Classification Product Code |
|
Date Received | 10/27/2003 |
Decision Date | 03/18/2004 |
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
|
|
|