CREATININE REAGENT SET (KINETIC)— 510(k) K880843
Substantially EquivalentTech-Neal Scientific, Inc.
FDA 510(k) clearance K880843 for CREATININE REAGENT SET (KINETIC), Substantially Equivalent on 1988-04-05. Applicant: Tech-Neal Scientific, Inc.. Device class: 2.
Clearance details
- Applicant
- Tech-Neal Scientific, Inc.
- Product code
- Code CGX
- Device class
- Class 2
- Regulation
- 21 CFR 862.1225
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Westmont, IL, US
Recent devices under product code CGX
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