DELFIA(TM) THYROXINE (T4) KIT— 510(k) K871303

Name: FDA 510(k) clearance K871303
Creator: U.S. Food and Drug Administration
Published: 1987-06-17

Substantially Equivalent

Lkb Instruments, Inc.

FDA 510(k) clearance K871303 for DELFIA(TM) THYROXINE (T4) KIT, Substantially Equivalent on 1987-06-17. Applicant: Lkb Instruments, Inc.. Device class: 2.

Clearance details

Applicant: Lkb Instruments, Inc.
Product code: Code CDX
Device class: Class 2
Regulation: 21 CFR 862.1700
Advisory panel: Clinical Chemistry
Date received: 1987-04-01
Decision date: 1987-06-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gaithersburg, MD, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CDX

view all

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

More clearances from Lkb Instruments, Inc.

view all

K874094 — 1205 BETAPLATE LIQUID SCINTILLATION COUNTER1987-11-04
K872955 — DELFIA(TM) FERRITIN KIT1987-08-21
K871599 — DELFIA(TM) HIGE KIT1987-06-12
K871644 — DELFIA (TM) HTSH KIT1987-05-12
K864452 — DELFIA(TM) TRIIODOTHYRONINE (T3) KIT1987-02-02

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