FORMICAL— 510(k) K821443
Substantially EquivalentLerner Laboratories, Inc.
FDA 510(k) clearance K821443 for FORMICAL, Substantially Equivalent on 1982-06-02. Applicant: Lerner Laboratories, Inc.. Device class: 1.
Clearance details
- Applicant
- Lerner Laboratories, Inc.
- Product code
- Code KDX
- Device class
- Class 1
- Regulation
- 21 CFR 864.4010
- Advisory panel
- Pathology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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