NDS THEOPHYLLINE TEST KIT & NDS TDM CALIBRATOR SET— 510(k) K900009
Substantially EquivalentKallestad Diag, A Div. of Erbamont, Inc.
FDA 510(k) clearance K900009 for NDS THEOPHYLLINE TEST KIT & NDS TDM CALIBRATOR SET, Substantially Equivalent on 1990-03-29. Applicant: Kallestad Diag, A Div. of Erbamont, Inc.. Device class: 2.
Clearance details
- Applicant
- Kallestad Diag, A Div. of Erbamont, Inc.
- Product code
- Code KLS
- Device class
- Class 2
- Regulation
- 21 CFR 862.3880
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chaska, MN, US
Recent devices under product code KLS
view allMore clearances from Kallestad Diag, A Div. of Erbamont, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.