IMMULITE DIGOXIN— 510(k) K914833

Substantially Equivalent

Cirrus Diagnostics, Inc.

FDA 510(k) clearance K914833 for IMMULITE DIGOXIN, Substantially Equivalent on 1991-11-22. Applicant: Cirrus Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Cirrus Diagnostics, Inc.
Product code: Code DPO
Device class: Class 2
Regulation: 21 CFR 862.3320
Advisory panel: Clinical Toxicology
Date received: 1991-10-25
Decision date: 1991-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chester, NJ, US

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K830962 — IMMUCHEM COVALENT-COAT RIA KIT1983-05-04

More clearances from Cirrus Diagnostics, Inc.

K921704 — IMMULITE(R) FSH1992-06-09
K920411 — IMMULITE HLH1992-03-11
K911796 — IMMULITE(TM) HCG1991-06-20
K910677 — IMMULITE(TM) T-UPTAKE1991-04-29
K910261 — IMMULITE(TM) TOTAL T41991-04-16

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