TOXOPLASMA IGM CLIN-ELISA(TM) CAT # 5560— 510(k) K874594

Substantially Equivalent

Clinical Sciences, Inc.

FDA 510(k) clearance K874594 for TOXOPLASMA IGM CLIN-ELISA(TM) CAT # 5560, Substantially Equivalent on 1988-03-07. Applicant: Clinical Sciences, Inc..

Clearance details

Applicant: Clinical Sciences, Inc.
Product code: Code LGD
Advisory panel: Microbiology
Date received: 1987-11-09
Decision date: 1988-03-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Whippany, NJ, US

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Adverse events under product code LGD

product code LGD

Malfunction: 502
Total: 502

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.