TERUMO SENSIBEAD EIA THYROID UPTAKE KIT— 510(k) K842694

Name: FDA 510(k) clearance K842694
Creator: U.S. Food and Drug Administration
Published: 1984-09-07

Substantially Equivalent

Terumo Medical Corp.

FDA 510(k) clearance K842694 for TERUMO SENSIBEAD EIA THYROID UPTAKE KIT, Substantially Equivalent on 1984-09-07. Applicant: Terumo Medical Corp.. Device class: 2.

Clearance details

Applicant: Terumo Medical Corp.
Product code: Code KHQ
Device class: Class 2
Regulation: 21 CFR 862.1715
Advisory panel: Clinical Chemistry
Date received: 1984-07-11
Decision date: 1984-09-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkton, MD, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KHQ

view all

K981375 — ACE T UPTAKE REAGENT TU CALIBRATORS1998-06-10
K980088 — T-UPTAKE MICROPLATE EIA1998-02-04
K970539 — CHIRON DIAGNOSTICS ACS:180TU P1997-03-24
K964308 — VITROS IMMUNODIAGNOSTICS PRODUCTS T3 UPTAKE REAGENT PACK (GEM.1025) AND T3 UPTAKE CALIBRATORS (GEM.C025)1996-11-27
K961488 — ELECSYS T-UPTAKE ASSAY1996-06-12

More clearances from Terumo Medical Corp.

view all

K111606 — PINNACLE PRECISION ACCESS SYSTEM2011-10-03
K111556 — GLIDECROSS SUPPORT CATHETER2011-07-29
K110540 — TERUMO SUPPORT CATHETER2011-05-13
K102008 — GLIDESHEATH2010-07-21
K091329 — PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH2009-05-29

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