Cleared Traditional

PACIFIC HEMOSTASIS REFERENCE EMULSION

K013397 · Fisher Diagnostics · Hematology
Feb 2002
Decision
123d
Days
Class 2
Risk

About This 510(k) Submission

K013397 is an FDA 510(k) clearance for the PACIFIC HEMOSTASIS REFERENCE EMULSION, a Calibrator, Multi-analyte Mixture (Class II — Special Controls, product code JIX), submitted by Fisher Diagnostics (Middletown, US). The FDA issued a Cleared decision on February 15, 2002, 123 days after receiving the submission on October 15, 2001. This device falls under the Hematology review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number K013397 FDA.gov
FDA Decision Cleared SESE
Date Received October 15, 2001
Decision Date February 15, 2002
Days to Decision 123 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement

Device Classification

Product Code JIX — Calibrator, Multi-analyte Mixture
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1150

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