CANDIDA DETECTION SYSTEM— 510(k) K823016

Name: FDA 510(k) clearance K823016
Creator: U.S. Food and Drug Administration
Published: 1982-12-28

Substantially Equivalent

Ramco Laboratories, Inc.

FDA 510(k) clearance K823016 for CANDIDA DETECTION SYSTEM, Substantially Equivalent on 1982-12-28. Applicant: Ramco Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Ramco Laboratories, Inc.
Product code: Code LHK
Device class: Class 2
Regulation: 21 CFR 866.3165
Advisory panel: Microbiology
Date received: 1982-10-12
Decision date: 1982-12-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LHK

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K893753 — DIRECTIGEN 1-2-3 DISSEMINATED CANDIDIASIS TEST1989-10-16
K812741 — REAGENTS FOR SERODIAGNOSIS OF CANDIDOSIS1981-10-23
K812186 — CANDIDA IMMUNODIFFUSION SYSTEM1981-08-25

More clearances from Ramco Laboratories, Inc.

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K983107 — VFE1998-10-22
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K910481 — EPO-RIA1991-11-29
K872941 — SPECTRO C1987-09-04
K864701 — VWF IMMUNOBLOT1987-03-30

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