DELFIA THYROXINE (T4) KIT— 510(k) K883559

Substantially Equivalent

Pharmacia, Inc.

FDA 510(k) clearance K883559 for DELFIA THYROXINE (T4) KIT, Substantially Equivalent on 1988-12-14. Applicant: Pharmacia, Inc.. Device class: 2.

Clearance details

Applicant: Pharmacia, Inc.
Product code: Code CDX
Device class: Class 2
Regulation: 21 CFR 862.1700
Advisory panel: Clinical Chemistry
Date received: 1988-08-19
Decision date: 1988-12-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Piscataway, NJ, 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

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K970420 — MASTERCAP AM 5.0/MASTERCAP RM 5.01997-06-30
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Data sourced from openFDA. This site is unofficial and independent of the FDA.