Chem-Chex

FDA 510(k) K900993 · Streck Laboratories, Inc.

Substantially Equivalent

510(k) numberK900993

Submission

Device name
Chem-Chex
Applicant
Streck Laboratories, Inc.
Omaha, NE, US
Received
March 2, 1990
Decision date
April 16, 1990
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JJY – Multi-Analyte Controls, All Kinds (Assayed)
Device class
Class I (low risk)
Regulation
21 CFR 862.1660
Specialty
Clinical Chemistry

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More from Aalto Scientific, Ltd.

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K042587Retic-Chex for Cell-DynJPK · Traditional 10/19/2004SE
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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 Chem-Chex cleared by the FDA?

Chem-Chex (K900993) received a 510(k) decision of Substantially Equivalent on April 16, 1990, 45 days after the submission was received.

What is the product code of K900993?

The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.