LEAP LE TEST KIT— 510(k) K842484
Substantially EquivalentCooper Biomedical, Inc.
FDA 510(k) clearance K842484 for LEAP LE TEST KIT, Substantially Equivalent on 1984-07-11. Applicant: Cooper Biomedical, Inc.. Device class: 2.
Clearance details
- Applicant
- Cooper Biomedical, Inc.
- Product code
- Code LKJ
- Device class
- Class 2
- Regulation
- 21 CFR 866.5100
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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