Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators, Immunalysis EDDP Urine Control Sets
FDA 510(k) clearance K151395 · decided 2015-07-24
Clearance details
- K-number
- K151395
- Device name
- Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators, Immunalysis EDDP Urine Control Sets
- Applicant
- Immunalysis Corporation
- Decision
- Substantially Equivalent
- Date received
- 2015-05-26
- Decision date
- 2015-07-24
- Days to decision
- 59 days
- Clearance type
- Traditional
- Product code
- DJR
- Device class
- 2
- Regulation number
- 862.3620
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Pomona, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.