TOXOPLASMA IGM ASSAY FOR THE BAYER IMMUNO1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)— 510(k) K971989
Substantially EquivalentBayer Corp.
FDA 510(k) clearance K971989 for TOXOPLASMA IGM ASSAY FOR THE BAYER IMMUNO1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM), Substantially Equivalent on 1997-10-22. 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.