IMMULITE HLH— 510(k) K920411

Substantially Equivalent

Cirrus Diagnostics, Inc.

FDA 510(k) clearance K920411 for IMMULITE HLH, Substantially Equivalent on 1992-03-11. Applicant: Cirrus Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Cirrus Diagnostics, Inc.
Product code: Code CEP
Device class: Class 1
Regulation: 21 CFR 862.1485
Advisory panel: Clinical Chemistry
Date received: 1992-01-31
Decision date: 1992-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chester, NJ, US

Download summary PDF View on FDA.gov ↗

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More clearances from Cirrus Diagnostics, Inc.

K921704 — IMMULITE(R) FSH1992-06-09
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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.