SERATEST ENA [SCL-70] KIT— 510(k) K894411
Substantially EquivalentHemagen Diagnostics, Inc.
FDA 510(k) clearance K894411 for SERATEST ENA [SCL-70] KIT, Substantially Equivalent on 1989-08-02. Applicant: Hemagen Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Hemagen Diagnostics, 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
- Waltham, MA, US
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