T4-RIA SINGLE REAGENT— 510(k) K832468

Substantially Equivalent

Fairlake Laboratories

FDA 510(k) clearance K832468 for T4-RIA SINGLE REAGENT, Substantially Equivalent on 1983-09-12. Applicant: Fairlake Laboratories. Device class: 2.

Clearance details

Applicant: Fairlake Laboratories
Product code: Code CDX
Device class: Class 2
Regulation: 21 CFR 862.1700
Advisory panel: Clinical Chemistry
Date received: 1983-07-25
Decision date: 1983-09-12
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 Fairlake Laboratories

K832469 — T3-RIA SINGLE REAGENT1983-09-12

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