IMMULITE(R) FSH— 510(k) K921704

Substantially Equivalent

Cirrus Diagnostics, Inc.

FDA 510(k) clearance K921704 for IMMULITE(R) FSH, Substantially Equivalent on 1992-06-09. Applicant: Cirrus Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Cirrus Diagnostics, Inc.
Product code: Code CGJ
Device class: Class 1
Regulation: 21 CFR 862.1300
Advisory panel: Clinical Chemistry
Date received: 1992-04-10
Decision date: 1992-06-09
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.

K920411 — IMMULITE HLH1992-03-11
K914833 — IMMULITE DIGOXIN1991-11-22
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.