T4 RIA TEST SYSTEM— 510(k) K771221

Substantially Equivalent

Monobind

FDA 510(k) clearance K771221 for T4 RIA TEST SYSTEM, Substantially Equivalent on 1977-08-04. 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: 1977-07-05
Decision date: 1977-08-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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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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

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