| Device Classification Name |
dna probe, nucleic acid amplification, chlamydia
|
|---|
| 510(K) Number |
K070174 |
|---|
| Device Name |
AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS; ROCHE SCRIPTS FOR CT/NG TEST ACCESSORY |
|---|
| Applicant |
| ROCHE DIAGNOSTICS CORPORATION |
| 9115 hague road |
|
indianapolis,
IN
46256
|
|
| Contact |
theresa ambrose bush |
| Regulation Number | 866.3120
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 01/18/2007 |
|---|
| Decision Date | 04/16/2007 |
|---|
| Decision |
substantially equivalent - CLIA submission (CS) |
|---|
| Classification Advisory Committee |
Microbiology
|
|---|
| Review Advisory Committee |
Microbiology
|
|---|
| summary |
summary
|
| FDA Review |
Decision Summary
|
|---|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Expedited Review |
No
|
|---|
| Combination Product |
No
|
|---|
|
|
