T4 BY RIA DIAG. KIT— 510(k) K771414

Substantially Equivalent

Biomedical Labs., Inc.

FDA 510(k) clearance K771414 for T4 BY RIA DIAG. KIT, Substantially Equivalent on 1977-09-22. Applicant: Biomedical Labs., Inc.. Device class: 2.

Clearance details

Applicant: Biomedical Labs., Inc.
Product code: Code CDX
Device class: Class 2
Regulation: 21 CFR 862.1700
Advisory panel: Clinical Chemistry
Date received: 1977-08-01
Decision date: 1977-09-22
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

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