AUTO I.D. JO-1, SCL-70 & PCNA POSITIVE CONTROL SERUM— 510(k) K030775
Substantially EquivalentImmuno Concepts, N.A. , Ltd.
FDA 510(k) clearance K030775 for AUTO I.D. JO-1, SCL-70 & PCNA POSITIVE CONTROL SERUM, Substantially Equivalent on 2003-05-12. Applicant: Immuno Concepts, N.A. , Ltd.. Device class: 2.
Clearance details
- Applicant
- Immuno Concepts, N.A. , Ltd.
- 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
- Abbreviated
- Location
- Dallas, TX, US
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