CBC-PLT-4/MULTIPLE WHOLE BLOOD HEMATOLOGY CONTROL— 510(k) K850755

Clearance details

Applicant

R&D Systems, Inc.

Product code

Code JPK

Device class

Class 2

Regulation

21 CFR 864.8625

Advisory panel

Hematology

Date received

1985-02-25

Decision date

1985-05-13

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Minneapolis, MN, US

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• Z-0429-2013 — Minotrol 16, Model Numbers: 2043748, 2043752, 2043756, Lot Number: MX090(Levels: Low, Normal, and High). Minotrol 16 is a tri-level control intended for in vitro diagnostic use in monitoring the accuracy and precision on HORIBA Medical hematology blood cell counters using HORIBA Medical reagents. Minotrol 16 is an in vitro diagnostic reagent composed of human erythrocytes, mammalian leukocytes, and platelets in a plasma-like fluid with preservatives. Minotrol 16 is a stable material that provides a means of determining the accuracy and precision of hematology blood cell counters. It is handled in the same manner as a patient specimen. The assay tables are determined on validated instruments using the appropriate reagentsClass III·Terminated·Horiba Instruments, Inc dba Horiba Medical·20120914

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K850755.