NO SPIN(TM) T3 COATED TUBE RADIOIMMUNOASSAY— 510(k) K873737

Name: FDA 510(k) clearance K873737
Creator: U.S. Food and Drug Administration
Published: 1987-11-24

Substantially Equivalent

Cambridge Medical Technology

FDA 510(k) clearance K873737 for NO SPIN(TM) T3 COATED TUBE RADIOIMMUNOASSAY, Substantially Equivalent on 1987-11-24. Applicant: Cambridge Medical Technology. Device class: 2.

Clearance details

Applicant: Cambridge Medical Technology
Product code: Code CDP
Device class: Class 2
Regulation: 21 CFR 862.1710
Advisory panel: Clinical Chemistry
Date received: 1987-09-15
Decision date: 1987-11-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Billerica, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CDP

view all

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 Cambridge Medical Technology

view all

K890837 — RIA-GNOST INSULIN1989-04-26
K890697 — RIA-GNOST FERRITIN1989-03-16
K890836 — RIA-GNOST PROGESTERONE1989-03-16
K870573 — T4 NO SPIN(TM) COATED TUBE RADIOIMMUNOASSAY KIT1987-04-22
K862871 — RADIOIMMUNOASSAY OF NO SPIN(TM) CORTISOL1986-08-19

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.