ENZYM-LINKED T3— 510(k) K820763

Name: FDA 510(k) clearance K820763
Creator: U.S. Food and Drug Administration
Published: 1982-04-15

Substantially Equivalent

Icl Scientific

FDA 510(k) clearance K820763 for ENZYM-LINKED T3, Substantially Equivalent on 1982-04-15. Applicant: Icl Scientific. Device class: 2.

Clearance details

Applicant: Icl Scientific
Product code: Code CDP
Device class: Class 2
Regulation: 21 CFR 862.1710
Advisory panel: Clinical Chemistry
Date received: 1982-03-22
Decision date: 1982-04-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K991311 — TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-10051999-06-02
K991252 — AIA-PACK FT3 ASSAY1999-05-11
K981824 — OPTICOAT T3 EIA KIT1998-12-22

More clearances from Icl Scientific

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K883942 — HYCOR SENTRY DRUGS OF ABUSE URINE CONTROL1988-11-10
K843565 — KOVA TROL I,II, III HUMAN URINE-DRIED1984-10-05
K833761 — THERAPEUTIC DRUG CONTROL1984-01-13
K832823 — ENZYMUNE-TEST TSH1983-10-14
K831383 — EVENT-TEST SLIDE1983-06-22

Adverse events under product code CDP

product code CDP

Malfunction: 647
Total: 647

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.