SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT, MODELS 684-25, 684-100P, 684-500P, 684-2000P, 683-20, 683-100P— 510(k) K992798
Substantially EquivalentSigma Diagnostics, Inc.
FDA 510(k) clearance K992798 for SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT, MODELS 684-25, 684-100P, 684-500P, 684-2000P, 683-20, 683-100P, Substantially Equivalent on 1999-09-28. Applicant: Sigma Diagnostics, Inc.. Device class: 1.
Clearance details
- Applicant
- Sigma Diagnostics, Inc.
- Product code
- Code CDO
- Device class
- Class 1
- Regulation
- 21 CFR 862.1775
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St. Louis, MO, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.