TOXOPLASMA IGG IN-VITRO DIAGNOSTIC SYSTEM— 510(k) K955760
Substantially EquivalentBayer Corp.
FDA 510(k) clearance K955760 for TOXOPLASMA IGG IN-VITRO DIAGNOSTIC SYSTEM, Substantially Equivalent on 1996-08-02. Applicant: Bayer Corp.. Device class: 2.
Clearance details
- Applicant
- Bayer Corp.
- Product code
- Code LGD
- Device class
- Class 2
- Regulation
- 21 CFR 866.3780
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tarrytown, NY, US
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Adverse events under product code LGD
product code LGD- Malfunction
- 502
- Total
- 502
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.