SIGMA DIAGNOSTICS INFINITY BUN REAGENT, MODELS 63-25, 63-100P, 63-500P, 63-2000P, 64-20, 64-100P— 510(k) K992800
Substantially EquivalentSigma Diagnostics, Inc.
FDA 510(k) clearance K992800 for SIGMA DIAGNOSTICS INFINITY BUN REAGENT, MODELS 63-25, 63-100P, 63-500P, 63-2000P, 64-20, 64-100P, Substantially Equivalent on 1999-09-28. Applicant: Sigma Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Sigma Diagnostics, Inc.
- Product code
- Code CDQ
- Device class
- Class 2
- Regulation
- 21 CFR 862.1770
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St. Louis, MO, US
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