ACS:CENTAUR CEA
FDA 510(k) clearance K981478 · decided 1998-08-12
Clearance details
- K-number
- K981478
- Device name
- ACS:CENTAUR CEA
- Applicant
- Chiron Diagnostics Corp.
- Decision
- Substantially Equivalent
- Date received
- 1998-04-24
- Decision date
- 1998-08-12
- Days to decision
- 110 days
- Clearance type
- Traditional
- Product code
- DHX
- Device class
- 2
- Regulation number
- 866.6010
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Medfield, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.