THYROXINE (T4) COATED TUBE RIA— 510(k) K921935

Substantially Equivalent

Monobind

FDA 510(k) clearance K921935 for THYROXINE (T4) COATED TUBE RIA, Substantially Equivalent on 1992-07-07. Applicant: Monobind. Device class: 2.

Clearance details

Applicant: Monobind
Product code: Code CDX
Device class: Class 2
Regulation: 21 CFR 862.1700
Advisory panel: Clinical Chemistry
Date received: 1992-04-24
Decision date: 1992-07-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Costa Mesa, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CDX

K961490 — ELECSYS T4 ASSAY1996-06-13
K954312 — ACTIVE THYROXINE RIA1995-10-07
K943416 — DELFIA NEONATAL THYROXINE KIT1995-03-10
K934384 — AXSYM(TM) TOTAL T41994-06-21
K932980 — TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-1161993-10-18

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Data sourced from openFDA. This site is unofficial and independent of the FDA.