SERATEST ENA [SSA] KIT— 510(k) K900617
Substantially EquivalentHemagen Diagnostics, Inc.
FDA 510(k) clearance K900617 for SERATEST ENA [SSA] KIT, Substantially Equivalent on 1990-02-23. Applicant: Hemagen Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Hemagen Diagnostics, Inc.
- Product code
- Code LLL
- Device class
- Class 2
- Regulation
- 21 CFR 866.5100
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Waltham, MA, US
Recent devices under product code LLL
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