IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/ALPHA-1 ANT
FDA 510(k) clearance K863868 · decided 1987-02-13
Clearance details
- K-number
- K863868
- Device name
- IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/ALPHA-1 ANT
- Applicant
- Cooper Biomedical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-10-03
- Decision date
- 1987-02-13
- Days to decision
- 133 days
- Clearance type
- Traditional
- Product code
- DFF
- Device class
- 2
- Regulation number
- 866.5080
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Malvern, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.