CA 15-3 ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
FDA 510(k) clearance K022178 · decided 2002-11-12
Clearance details
- K-number
- K022178
- Device name
- CA 15-3 ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
- Applicant
- Bayer Diagnostics Corp.
- Decision
- Substantially Equivalent
- Date received
- 2002-07-03
- Decision date
- 2002-11-12
- Days to decision
- 132 days
- Clearance type
- Traditional
- Product code
- MOI
- Device class
- 2
- Regulation number
- 866.6010
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Tarrytown, NY, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Bayer Diagnostics Corp.
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.