Cleared Traditional

SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A)

K971858 · Sigma Diagnostics, Inc. · Hematology
Oct 1997
Decision
142d
Days
Class 2
Risk

About This 510(k) Submission

K971858 is an FDA 510(k) clearance for the SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A), a System, Fibrinogen Determination (Class II — Special Controls, product code KQJ), submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on October 9, 1997, 142 days after receiving the submission on May 20, 1997. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7340.

Submission Details

510(k) Number K971858 FDA.gov
FDA Decision Cleared SESE
Date Received May 20, 1997
Decision Date October 09, 1997
Days to Decision 142 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code KQJ — System, Fibrinogen Determination
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7340

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