QUANTIMUNE NEONATAL & THYROXINE RIA— 510(k) K771135

Substantially Equivalent

Bio-Rad

FDA 510(k) clearance K771135 for QUANTIMUNE NEONATAL & THYROXINE RIA, Substantially Equivalent on 1977-07-14. Applicant: Bio-Rad. Device class: 2.

Clearance details

Applicant: Bio-Rad
Product code: Code CDX
Device class: Class 2
Regulation: 21 CFR 862.1700
Advisory panel: Clinical Chemistry
Date received: 1977-06-23
Decision date: 1977-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CDX

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K954312 — ACTIVE THYROXINE RIA1995-10-07
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K934384 — AXSYM(TM) TOTAL T41994-06-21
K932980 — TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-1161993-10-18

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