AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS; ROCHE SCRIPTS FOR CT/NG TEST ACCESSORY
FDA 510(k) clearance K070174 · decided 2007-04-16
Clearance details
- K-number
- K070174
- Device name
- AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS; ROCHE SCRIPTS FOR CT/NG TEST ACCESSORY
- Applicant
- Roche Diagnostics Corporation
- Decision
- Substantially Equivalent
- Date received
- 2007-01-18
- Decision date
- 2007-04-16
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- MKZ
- Device class
- 1
- Regulation number
- 866.3120
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Roche Diagnostics Corporation
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.