DATA-TOPE T4 RIA PROCEDURE— 510(k) K761282

Name: FDA 510(k) clearance K761282
Creator: U.S. Food and Drug Administration
Published: 1976-12-30

Substantially Equivalent

Dade, Baxter Travenol Diagnostics, Inc.

FDA 510(k) clearance K761282 for DATA-TOPE T4 RIA PROCEDURE, Substantially Equivalent on 1976-12-30. Applicant: Dade, Baxter Travenol Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Dade, Baxter Travenol Diagnostics, Inc.
Product code: Code CDX
Device class: Class 2
Regulation: 21 CFR 862.1700
Advisory panel: Clinical Chemistry
Date received: 1976-12-20
Decision date: 1976-12-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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 Dade, Baxter Travenol Diagnostics, Inc.

view all

K800296 — WHOLE BLOOD GAS CONTROL, LEVELS 1,2,&31980-03-05
K792606 — WHOLE BLOOD PLATELET CONTROL NORMAL,1980-02-13
K792723 — BLOOD FLUID FILTERS1980-01-21
K792607 — T3 UPTAKE (T3U) REAGENTS1980-01-16
K792443 — TSH RADIOIMMUNOASSAY1979-12-27

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