TECH SIMPLE INFECTIOUS MONONUCLEOSIS SERUM CONTROL— 510(k) K922726
Substantially EquivalentSimplicity Diagnostics, Inc.
FDA 510(k) clearance K922726 for TECH SIMPLE INFECTIOUS MONONUCLEOSIS SERUM CONTROL, Substantially Equivalent on 1992-10-05. Applicant: Simplicity Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Simplicity Diagnostics, Inc.
- Product code
- Code KTN
- Device class
- Class 2
- Regulation
- 21 CFR 866.5640
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hatboro, PA, US
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