BACT/ALERT BLOOD COLLECTION ADAPTER CAP AND INSERT— 510(k) K933939
Substantially EquivalentOrganon Teknika Corp.
FDA 510(k) clearance K933939 for BACT/ALERT BLOOD COLLECTION ADAPTER CAP AND INSERT, Substantially Equivalent on 1994-02-07. Applicant: Organon Teknika Corp.. Device class: 2.
Clearance details
- Applicant
- Organon Teknika Corp.
- Product code
- Code GIM
- Device class
- Class 2
- Regulation
- 21 CFR 862.1675
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Durham, NC, US
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More clearances from Organon Teknika Corp.
view allAdverse events under product code GIM
product code GIM- Malfunction
- 1,325
- Total
- 1,325
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.