510(k) K924186
- Device
- LPIA-FERRITIN ASSAY
- Applicant
- SERADYN, INC.
- 510(k) number
- K924186
- Product code
- DEF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-12-23
- Date received
- 1992-08-20
- Regulation
- 866.5425
- Classification name
- Alpha-2-hs-glycoprotein, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ANDRIS INDRIKSONS
- Address
- P.O. Box 1210 Indianapolis IN US 46206 46206
FDA Registration Numbers#
- 3006198300
Source Documents#
Legacy Summary#
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FDA Review#
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