Cleared Traditional

HEMAGEN CMV IGG KIT

K944438 · Hemagen Diagnostics, Inc. · Microbiology
Feb 1997
Decision
892d
Days
Class 2
Risk

About This 510(k) Submission

K944438 is an FDA 510(k) clearance for the HEMAGEN CMV IGG KIT, a Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus (Class II — Special Controls, product code LFZ), submitted by Hemagen Diagnostics, Inc. (Waltham, US). The FDA issued a Cleared decision on February 20, 1997, 892 days after receiving the submission on September 12, 1994. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3175.

Submission Details

510(k) Number K944438 FDA.gov
FDA Decision Cleared SESE
Date Received September 12, 1994
Decision Date February 20, 1997
Days to Decision 892 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LFZ — Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3175

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