Para 5X

FDA 510(k) K011410 · Streck Laboratories, Inc.

Substantially Equivalent

510(k) numberK011410

Submission

Device name
Para 5X
Applicant
Streck Laboratories, Inc.
La Vista, NE, US
Received
May 8, 2001
Decision date
June 26, 2001
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JPK – Mixture, Hematology Quality Control
Device class
Class II (moderate risk)
Regulation
21 CFR 864.8625
Specialty
Hematology

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More from R&D Systems, Inc.

510(k)DeviceDecision
K042587Retic-Chex for Cell-DynJPK · Traditional 10/19/2004SE
K040107Cyto-Chex BCTJKA · Traditional 07/27/2004SE
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
K001443Sugar Chex OneJJX · Traditional 06/29/2000SE
K000945Para 12 Plus ReticsGLQ · Traditional 04/18/2000SE
K000115Retic Chex LinearityJPK · Traditional 03/27/2000SE

Questions and answers

When was Para 5X cleared by the FDA?

Para 5X (K011410) received a 510(k) decision of Substantially Equivalent on June 26, 2001, 49 days after the submission was received.

What is the product code of K011410?

The FDA product code is JPK – Mixture, Hematology Quality Control, a Class II (moderate risk) device regulated under 21 CFR 864.8625.