LD-1(IMMUNO) SEPARATION SET— 510(k) K851521
Substantially EquivalentSeragen Diagnostics, Inc.
FDA 510(k) clearance K851521 for LD-1(IMMUNO) SEPARATION SET, Substantially Equivalent on 1985-05-10. Applicant: Seragen Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Seragen Diagnostics, Inc.
- Product code
- Code CEX
- Device class
- Class 2
- Regulation
- 21 CFR 862.1445
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
Recent devices under product code CEX
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