CHIRON DIAGNOSTICS ACS: 180 FOLATE
FDA 510(k) clearance K991582 · decided 1999-06-30
Clearance details
- K-number
- K991582
- Device name
- CHIRON DIAGNOSTICS ACS: 180 FOLATE
- Applicant
- Chiron Diagnostics Corp.
- Decision
- Substantially Equivalent
- Date received
- 1999-05-07
- Decision date
- 1999-06-30
- Days to decision
- 54 days
- Clearance type
- Traditional
- Product code
- CGN
- Device class
- 2
- Regulation number
- 862.1295
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- 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.