T4 RIA— 510(k) K833850

Substantially Equivalent

Syncor Intl. Corp.

FDA 510(k) clearance K833850 for T4 RIA, Substantially Equivalent on 1984-01-18. Applicant: Syncor Intl. Corp.. Device class: 2.

Clearance details

Applicant: Syncor Intl. Corp.
Product code: Code CDX
Device class: Class 2
Regulation: 21 CFR 862.1700
Advisory panel: Clinical Chemistry
Date received: 1983-11-04
Decision date: 1984-01-18
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

More clearances from Syncor Intl. Corp.

K945825 — SECURE SAFETY INSERT1995-04-10
K851828 — IRRADIATOR FOR BIOLOGICAL MATERIALS IBL-437-C1985-09-19
K850433 — CESIUM 137 ENDOMETRIAL SOURCE1985-08-21
K852023 — CESIUM 137 SOURCE, CSM-4, CSM-11, CSM-411985-08-21
K852665 — SYNCOR TRICH DIRECT IMMUNOFLUORESCENCE ASSAY1985-08-13

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