3M INTEGRATED CYCLER (110V) & (220V)— 510(k) K102314
Substantially EquivalentFocus Diagnostics, Inc.
FDA 510(k) clearance K102314 for 3M INTEGRATED CYCLER (110V) & (220V), Substantially Equivalent on 2010-10-29. Applicant: Focus Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Focus Diagnostics, Inc.
- Product code
- Code OOI
- Device class
- Class 2
- Regulation
- 21 CFR 862.2570
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cypress, CA, US
Recent devices under product code OOI
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view all- K152408 — Simplexa Flu A/B & RSV Direct and Simplexa Flu A/B & RSV Positive Control Pack
- K143651 — Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control Pack
- K120986 — STRATIFY JCV DXSELECT
- K120413 — SIMPLEXA FLU A/B & RSV DIRECT, SIMPLEXA FLU A/B & RSV POSITIVE CONTROL PACK
- K113433 — SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT
Adverse events under product code OOI
product code OOI- Malfunction
- 2,506
- Other
- 3
- Total
- 2,509
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.