TOTAL T3-RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT— 510(k) K870968

Name: FDA 510(k) clearance K870968
Creator: U.S. Food and Drug Administration
Published: 1987-06-22

Substantially Equivalent

Canadian Bioclinical, Ltd.

FDA 510(k) clearance K870968 for TOTAL T3-RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT, Substantially Equivalent on 1987-06-22. Applicant: Canadian Bioclinical, Ltd.. Device class: 2.

Clearance details

Applicant: Canadian Bioclinical, Ltd.
Product code: Code CDP
Device class: Class 2
Regulation: 21 CFR 862.1710
Advisory panel: Clinical Chemistry
Date received: 1987-03-10
Decision date: 1987-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ontario Mix 1b4, CA

Download summary PDF View on FDA.gov ↗

Recent devices under product code CDP

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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

More clearances from Canadian Bioclinical, Ltd.

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K933794 — ANI BIOCARD(TM) HCG TEST1994-05-19
K870969 — CORTISOL-RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT1987-06-22
K864449 — DIGOXIN/RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT1987-02-02

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.