Cell-Chex RBC

FDA 510(k) K811741 · Streck Laboratories, Inc.

Substantially Equivalent

510(k) numberK811741

Submission

Device name
Cell-Chex RBC
Applicant
Streck Laboratories, Inc.
Mchenry, IL, US
Received
June 19, 1981
Decision date
September 24, 1981
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KRX – Calibrator For Cell Indices
Device class
Class II (moderate risk)
Regulation
21 CFR 864.8150
Specialty
Hematology

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K020469Cal-Chex CD PlusKRX · Traditional Streck Laboratories, Inc.04/04/2002SE
K003991Cd-Cal Plus CalibratorKRX · Special R&D Systems, Inc.01/16/2001SE
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More from Clinical Diagnostic Solutions, Inc.

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K040025A1C-CELLULARJJX · Traditional 03/02/2004SE
K023656Sickle-Chex Solubility KitGHM · Traditional 12/30/2002SE
K021922Modification to Para 5XJPK · Special 06/25/2002SE
K020469Cal-Chex CD PlusKRX · Traditional 04/04/2002SE
K013316Sickle-ChexGHM · Traditional 11/06/2001SE
K011410Para 5XJPK · Traditional 06/26/2001SE
K001443Sugar Chex OneJJX · Traditional 06/29/2000SE
K000945Para 12 Plus ReticsGLQ · Traditional 04/18/2000SE

Questions and answers

When was Cell-Chex RBC cleared by the FDA?

Cell-Chex RBC (K811741) received a 510(k) decision of Substantially Equivalent on September 24, 1981, 97 days after the submission was received.

What is the product code of K811741?

The FDA product code is KRX – Calibrator For Cell Indices, a Class II (moderate risk) device regulated under 21 CFR 864.8150.