SYN ELISA DSDNA ANTIBODIES
FDA 510(k) clearance K921132 · decided 1992-12-01
Clearance details
- K-number
- K921132
- Device name
- SYN ELISA DSDNA ANTIBODIES
- Applicant
- Elias U.S.A., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-03-10
- Decision date
- 1992-12-01
- Days to decision
- 266 days
- Clearance type
- Traditional
- Product code
- LKJ
- Device class
- 2
- Regulation number
- 866.5100
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Osceola, WI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.