SERAGAN ACTH125 I-RIA KIT— 510(k) K822115
Substantially EquivalentSeragen Diagnostics, Inc.
FDA 510(k) clearance K822115 for SERAGAN ACTH125 I-RIA KIT, Substantially Equivalent on 1982-10-18. Applicant: Seragen Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Seragen Diagnostics, Inc.
- Product code
- Code CKG
- Device class
- Class 2
- Regulation
- 21 CFR 862.1025
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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