TOTAL TRIIODOTHYRONINE(T3) MICROPLATE EIA— 510(k) K971779

Name: FDA 510(k) clearance K971779
Creator: U.S. Food and Drug Administration
Published: 1997-06-16

Substantially Equivalent

Monobind

FDA 510(k) clearance K971779 for TOTAL TRIIODOTHYRONINE(T3) MICROPLATE EIA, Substantially Equivalent on 1997-06-16. Applicant: Monobind. Device class: 2.

Clearance details

Applicant: Monobind
Product code: Code CDP
Device class: Class 2
Regulation: 21 CFR 862.1710
Advisory panel: Clinical Chemistry
Date received: 1997-05-14
Decision date: 1997-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Costa Mesa, CA, 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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K030860 — ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-3002003-08-22
K020548 — FREE T4 (THYTOXINE) MICROPLATE EIA TEST MODELS # 1225-3002002-04-05
K980088 — T-UPTAKE MICROPLATE EIA1998-02-04
K972720 — FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300)1997-09-02
K971834 — ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISA1997-07-03

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.