IMMUBEAD T3 ENZYME IMMUNOASSAY KIT— 510(k) K872191

Name: FDA 510(k) clearance K872191
Creator: U.S. Food and Drug Administration
Published: 1987-08-13

Substantially Equivalent

Immunotech Corp.

FDA 510(k) clearance K872191 for IMMUBEAD T3 ENZYME IMMUNOASSAY KIT, Substantially Equivalent on 1987-08-13. Applicant: Immunotech Corp.. Device class: 2.

Clearance details

Applicant: Immunotech Corp.
Product code: Code CDP
Device class: Class 2
Regulation: 21 CFR 862.1710
Advisory panel: Clinical Chemistry
Date received: 1987-06-08
Decision date: 1987-08-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boston, MA, US

Download summary PDF View on FDA.gov ↗

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K001607 — REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104)2000-10-05
K991692 — CHIRON DIAGNOSTICS ACS: 180 FT31999-06-18
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

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K954188 — OPTICLONE IGG1 FITC/IGG2A PE ISOTYPIC CONTROL1995-11-03
K952789 — OPTICLONE CD4FITC/CD8 PE MONOCLONAL ANTIBODIES1995-08-14
K950626 — OPTICLONE CD3/CD4 MONOCLONAL ANTIBODIES1995-05-05
K931228 — PROGESTERONE RADIOIMMUNOASSAY KIT1993-10-22
K911634 — MICROZYME(TM) FREE T4 ENZYME IMMUNOASSAY TEST1991-06-24

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.