STRAT TOTAL THYROXINE FLUOROMET ENZYME IMMUNOASSAY— 510(k) K860421

Name: FDA 510(k) clearance K860421
Creator: U.S. Food and Drug Administration
Published: 1986-02-11

Substantially Equivalent

American Dade

FDA 510(k) clearance K860421 for STRAT TOTAL THYROXINE FLUOROMET ENZYME IMMUNOASSAY, Substantially Equivalent on 1986-02-11. Applicant: American Dade. Device class: 2.

Clearance details

Applicant: American Dade
Product code: Code CDX
Device class: Class 2
Regulation: 21 CFR 862.1700
Advisory panel: Clinical Chemistry
Date received: 1986-02-04
Decision date: 1986-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CDX

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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

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K873171 — STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY1987-09-29
K873052 — STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAY1987-09-14
K872789 — PARAMAX URINE/CSF CALIBRATOR1987-09-02
K872195 — DATA-FI DIMERTEST LATEX ASSAY1987-08-06

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