NDS CORTISOL TEST KIT AND NDS CORTISOL CALIBRATOR— 510(k) K900010
Substantially EquivalentKallestad Diag, A Div. of Erbamont, Inc.
FDA 510(k) clearance K900010 for NDS CORTISOL TEST KIT AND NDS CORTISOL CALIBRATOR, Substantially Equivalent on 1990-04-03. Applicant: Kallestad Diag, A Div. of Erbamont, Inc.. Device class: 2.
Clearance details
- Applicant
- Kallestad Diag, A Div. of Erbamont, Inc.
- Product code
- Code JFT
- Device class
- Class 2
- Regulation
- 21 CFR 862.1205
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chaska, MN, US
Recent devices under product code JFT
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