Cleared Traditional

FIBRINOGEN SCREEN

K800826 · Pacific Hemostasis · Hematology
May 1980
Decision
46d
Days
Class 2
Risk

About This 510(k) Submission

K800826 is an FDA 510(k) clearance for the FIBRINOGEN SCREEN, a System, Fibrinogen Determination (Class II — Special Controls, product code KQJ), submitted by Pacific Hemostasis (Mchenry, US). The FDA issued a Cleared decision on May 30, 1980, 46 days after receiving the submission on April 14, 1980. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7340.

Submission Details

510(k) Number K800826 FDA.gov
FDA Decision Cleared SESE
Date Received April 14, 1980
Decision Date May 30, 1980
Days to Decision 46 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

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

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