SIGMA DIAGNOSTICS ALEXIN HS, MODELS A0969, A1094— 510(k) K992711
Substantially EquivalentSigma Diagnostics, Inc.
FDA 510(k) clearance K992711 for SIGMA DIAGNOSTICS ALEXIN HS, MODELS A0969, A1094, Substantially Equivalent on 1999-12-06. Applicant: Sigma Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Sigma Diagnostics, Inc.
- Product code
- Code GFO
- Device class
- Class 2
- Regulation
- 21 CFR 864.7925
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St. Louis, MO, US
Recent devices under product code GFO
view allMore 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.