ACTH IMMUNORADIOMETRIC (IRMA) DIAGNOSTIC ASSAY KIT, MODEL #3KG100— 510(k) K021032
Substantially EquivalentScantibodies Laboratory, Inc.
FDA 510(k) clearance K021032 for ACTH IMMUNORADIOMETRIC (IRMA) DIAGNOSTIC ASSAY KIT, MODEL #3KG100, Substantially Equivalent on 2002-06-03. Applicant: Scantibodies Laboratory, Inc.. Device class: 2.
Clearance details
- Applicant
- Scantibodies Laboratory, 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
- Santee, CA, US
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