BACT/ALERT SN— 510(k) K993421
Substantially EquivalentOrganon Teknika Corp.
FDA 510(k) clearance K993421 for BACT/ALERT SN, Substantially Equivalent on 1999-12-14. Applicant: Organon Teknika Corp.. Device class: 1.
Clearance details
- Applicant
- Organon Teknika Corp.
- Product code
- Code MDB
- Device class
- Class 1
- Regulation
- 21 CFR 866.2560
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Durham, NC, US
Recent devices under product code MDB
view allMore clearances from Organon Teknika Corp.
view allAdverse events under product code MDB
product code MDB- Death
- 6
- Malfunction
- 5,490
- Total
- 5,496
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 →
Recalls naming K993421
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K993421.
Data sourced from openFDA. This site is unofficial and independent of the FDA.