ACTH IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG011— 510(k) K050748
Substantially EquivalentScantibodies Laboratory, Inc.
FDA 510(k) clearance K050748 for ACTH IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG011, Substantially Equivalent on 2005-05-20. 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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More clearances from Scantibodies Laboratory, Inc.
view all- K060578 — CALCITONIN IMMUNORADIOMETRIC ASSAY (IRMA) (COATED TUBE VERSION)
- K060420 — MODIFICATION TO WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILLUMINOMETRIC (ICMA) ASSAY KIT, MODEL 3KG002
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- K051888 — TOTAL INTACT PTH IMMUNORADIOMETRIC ASSAY (COATED TUBE VERSION), MODEL 3KG013
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