COBAS(R) CORE FT4 EIA
FDA 510(k) clearance K932607 · decided 1994-01-24
Clearance details
- K-number
- K932607
- Device name
- COBAS(R) CORE FT4 EIA
- Applicant
- Roche Diagnostic Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-05-28
- Decision date
- 1994-01-24
- Days to decision
- 241 days
- Clearance type
- Traditional
- Product code
- CEC
- Device class
- 2
- Regulation number
- 862.1695
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Branchburg, NJ, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Roche Diagnostic Systems
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.