IMMPULSE CORTISOL ASSAY REAGENTS— 510(k) K842554

Substantially Equivalent

Aktis 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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