AMDL-ELISA DR-70 (FDP) IMMUNOASSAY, MODEL DR2101
FDA 510(k) clearance K072901 · decided 2008-07-01
Clearance details
- K-number
- K072901
- Device name
- AMDL-ELISA DR-70 (FDP) IMMUNOASSAY, MODEL DR2101
- Applicant
- Amdl, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-10-11
- Decision date
- 2008-07-01
- Days to decision
- 264 days
- Clearance type
- Traditional
- Product code
- NTY
- Device class
- 2
- Regulation number
- 866.6010
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Tustin, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.