REAGENTS FOR SERODIAGNOSIS OF CANDIDOSIS— 510(k) K812741

Name: FDA 510(k) clearance K812741
Creator: U.S. Food and Drug Administration
Published: 1981-10-23

Substantially Equivalent

Nolan Biological Laboratories, Inc.

FDA 510(k) clearance K812741 for REAGENTS FOR SERODIAGNOSIS OF CANDIDOSIS, Substantially Equivalent on 1981-10-23. Applicant: Nolan Biological Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Nolan Biological Laboratories, Inc.
Product code: Code LHK
Device class: Class 2
Regulation: 21 CFR 866.3165
Advisory panel: Microbiology
Date received: 1981-09-29
Decision date: 1981-10-23
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
K823016 — CANDIDA DETECTION SYSTEM1982-12-28
K812186 — CANDIDA IMMUNODIFFUSION SYSTEM1981-08-25

More clearances from Nolan Biological Laboratories, Inc.

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K812740 — REAGENTS FOR SERODIAGNOSIS OF ASPERGILL1981-10-20
K802128 — IMMUNODIFFUSSION REAGENTS/SEROLOGICAL1980-09-26
K802129 — IMMUNODIFFUSION REAGENTS/SEROLOGICAL1980-09-26
K802130 — IMMUNO. IDENTIFICATION OF H. CAPSULATUM1980-09-26

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