Who is the manufacturer of CBC-SF?

R&D Systems, Inc. submitted the Traditional clearance for CBC-SF (K010409).

What is the FDA product code for CBC-SF?

JPK. It is classified under 21 CFR 864.8625 as a Class 2 device in the Hematology panel.

What is the regulatory pathway for CBC-SF?

510(k) clearance (submission type: Traditional).

CBC-SF

K010409 · R&D Systems, Inc. · JPK · Mar 16, 2001 · Hematology

Device Facts

Record ID	K010409
Device Name	CBC-SF
Applicant	R&D Systems, Inc.
Product Code	JPK · Hematology
Decision Date	Mar 16, 2001
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 864.8625
Device Class	Class 2

Regulatory Classification

Identification

A hematology quality control mixture is a device used to ascertain the accuracy and precision of manual, semiautomated, and automated determinations of cell parameters such as white cell count (WBC), red cell count (RBC), platelet count (PLT), hemoglobin, hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC).

Special Controls

*Classification.* Class II (special controls). Except when intended for use in blood components, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.