IMMPULSE CORTISOL ASSAY REAGENTS— 510(k) K842554
Substantially EquivalentAktis Corp.
FDA 510(k) clearance K842554 for IMMPULSE CORTISOL ASSAY REAGENTS, Substantially Equivalent on 1984-08-12. Applicant: Aktis Corp.. Device class: 2.
Clearance details
- Applicant
- Aktis Corp.
- Product code
- Code CGR
- Device class
- Class 2
- Regulation
- 21 CFR 862.1205
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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