SR-PLUS DIRECT CHOLESTEROL TEST— 510(k) K780545
Substantially EquivalentStanbio Laboratory
FDA 510(k) clearance K780545 for SR-PLUS DIRECT CHOLESTEROL TEST, Substantially Equivalent on 1978-05-26. Applicant: Stanbio Laboratory. Device class: 1.
Clearance details
- Applicant
- Stanbio Laboratory
- Product code
- Code CGO
- Device class
- Class 1
- Regulation
- 21 CFR 862.1175
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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