ST AIA-PACK CEA ENZYME IMMUNOASSAY
FDA 510(k) clearance K023893 · decided 2002-12-18
Clearance details
- K-number
- K023893
- Device name
- ST AIA-PACK CEA ENZYME IMMUNOASSAY
- Applicant
- Tosoh Medics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-11-22
- Decision date
- 2002-12-18
- Days to decision
- 26 days
- Clearance type
- Special
- Product code
- DHX
- Device class
- 2
- Regulation number
- 866.6010
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- South San Francisco, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.