SIGMA DIAGNOSTICS ACCUCLOT CONTROL III— 510(k) K981255
Substantially EquivalentSigma Diagnostics, Inc.
FDA 510(k) clearance K981255 for SIGMA DIAGNOSTICS ACCUCLOT CONTROL III, Substantially Equivalent on 1998-04-29. Applicant: Sigma Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Sigma Diagnostics, Inc.
- Product code
- Code GGN
- Device class
- Class 2
- Regulation
- 21 CFR 864.5425
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St. Louis, MO, US
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- 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.