SEALITE SCIENCES, INC. AQUALITE FERRITIN ASSAY— 510(k) K970612
Substantially EquivalentSealite Sciences, Inc.
FDA 510(k) clearance K970612 for SEALITE SCIENCES, INC. AQUALITE FERRITIN ASSAY, Substantially Equivalent on 1997-06-24. Applicant: Sealite Sciences, Inc.. Device class: 2.
Clearance details
- Applicant
- Sealite Sciences, Inc.
- Product code
- Code DBF
- Device class
- Class 2
- Regulation
- 21 CFR 866.5340
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Norcross, GA, US
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