SIGMA DIAGNOSTICS INFINITY GLUCOSE REAGENT, MODELS 17-25, 17-100P, 17-500P, 17-2000P, 18-20, 18-100P— 510(k) K001403
Substantially EquivalentSigma Diagnostics, Inc.
FDA 510(k) clearance K001403 for SIGMA DIAGNOSTICS INFINITY GLUCOSE REAGENT, MODELS 17-25, 17-100P, 17-500P, 17-2000P, 18-20, 18-100P, Substantially Equivalent on 2000-08-10. Applicant: Sigma Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Sigma Diagnostics, Inc.
- Product code
- Code CFR
- Device class
- Class 2
- Regulation
- 21 CFR 862.1345
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St. Louis, MO, US
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- K170316 — ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM
More clearances from Sigma Diagnostics, Inc.
view all- K021162 — AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHED
- K020109 — SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL
- K013549 — SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971
- K013544 — SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096
- K013545 — SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221
Data sourced from openFDA. This site is unofficial and independent of the FDA.