SIGMA DIAGNOSTICS INFINITY CHOLESTEROL REAGENT, MODELS 401-25, 401-100P, 401-500P, 401-2000P, 402-20, 02-1OOP— 510(k) K992803
Substantially EquivalentSigma Diagnostics, Inc.
FDA 510(k) clearance K992803 for SIGMA DIAGNOSTICS INFINITY CHOLESTEROL REAGENT, MODELS 401-25, 401-100P, 401-500P, 401-2000P, 402-20, 02-1OOP, Substantially Equivalent on 1999-09-13. Applicant: Sigma Diagnostics, Inc.. Device class: 1.
Clearance details
- Applicant
- Sigma Diagnostics, Inc.
- Product code
- Code CHH
- Device class
- Class 1
- Regulation
- 21 CFR 862.1175
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St. Louis, MO, US
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