TOXOELISA TEST KIT— 510(k) K813221

Name: FDA 510(k) clearance K813221
Creator: U.S. Food and Drug Administration
Published: 1982-01-26

Substantially Equivalent

M.A. Bioproducts

FDA 510(k) clearance K813221 for TOXOELISA TEST KIT, Substantially Equivalent on 1982-01-26. Applicant: M.A. Bioproducts. Device class: 2.

Clearance details

Applicant: M.A. Bioproducts
Product code: Code LGD
Device class: Class 2
Regulation: 21 CFR 866.3780
Advisory panel: Microbiology
Date received: 1981-11-09
Decision date: 1982-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from M.A. Bioproducts

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K822883 — HERPELISA KIT1983-07-26
K823804 — MYCOPLASMELISA TEST KIT1983-05-25
K830045 — MUMPSELISA TEST KIT1983-05-13
K830615 — CYTOMEGELISA STAT1983-05-09
K823805 — VARICELISA TEST KIT1983-05-05

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.