TOTAL T-3 FPIA REAGENT SET, TOTAL T-3 FPIA CALIBRATORS— 510(k) K952557
Substantially EquivalentSigma Diagnostics, Inc.
FDA 510(k) clearance K952557 for TOTAL T-3 FPIA REAGENT SET, TOTAL T-3 FPIA CALIBRATORS, Substantially Equivalent on 1996-01-24. Applicant: Sigma Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Sigma Diagnostics, Inc.
- Product code
- Code CDP
- Device class
- Class 2
- Regulation
- 21 CFR 862.1710
- Advisory panel
- Clinical Chemistry
- 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
Adverse events under product code CDP
product code CDP- Malfunction
- 647
- Total
- 647
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.