TOXOPLASMA IGM ELISA TEST SYSTEM— 510(k) K913787
Substantially EquivalentZeus Scientific, Inc.
FDA 510(k) clearance K913787 for TOXOPLASMA IGM ELISA TEST SYSTEM, Substantially Equivalent on 1991-12-18. Applicant: Zeus Scientific, Inc.. Device class: 2.
Clearance details
- Applicant
- Zeus Scientific, Inc.
- 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
- Raritan, NJ, US
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- K113397 — ZEUS ELISA BORRELIA VLSE-1/PEPC10 IGG/IGM TEST SYSTEM
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.