Biotrack Theophylline Quality Controls

FDA 510(k) K903924 · Biotrack, Inc.

Substantially Equivalent

510(k) numberK903924

Submission

Device name
Biotrack Theophylline Quality Controls
Applicant
Biotrack, Inc.
Mountain View, CA, US
Received
August 24, 1990
Decision date
September 17, 1990
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
LAW – Theophylline Control Materials
Device class
Class I (low risk)
Regulation
21 CFR 862.3280
Specialty
Clinical Toxicology

Other 510(k)s with product code LAW

510(k)DeviceApplicantDecision
K920223Chem Chex Theophylline ControlLAW · Traditional Streck Laboratories, Inc.06/10/1992SE
K914251Model Irc Passport NebulizerLAW · Traditional Invacare Corp.01/24/1992SE
K871589Theophylline Fpia ControlsLAW · Traditional Sigma Chemical Co.06/17/1987SE

More from Sigma Chemical Co.

510(k)DeviceDecision
K934062Biotrack Therapeutic Drug-Monitoring Qual ControlsDIF · Traditional 12/29/1993SE
K934061Biotrack Valproic Acid Test CartridgeLEG · Traditional 12/29/1993SE
K920525Biotrack Therapeutic Drug Monitoring Qual. ControlDIS · Traditional 08/05/1992SE
K915756Biotrack Carbamazepine Test CartridgeKLT · Traditional 07/23/1992SE
K915755Biotrack Phenytoin Test CartridgeDIP · Traditional 07/23/1992SE
K900373Biotrack Theophylline Test CartridgeKLS · Traditional 05/30/1990SE
K900372Biotrack Immunochemistry MonitorJJQ · Traditional 02/23/1990SE
K895102Biotrack PDS MonitorJJQ · Traditional 10/10/1989SE
K895101Biotrack Hemoglobin Test CartridgeKHG · Traditional 10/10/1989SE
K895128Biotrack Alt Test CartridgeCJJ · Traditional 10/06/1989SE

Questions and answers

When was Biotrack Theophylline Quality Controls cleared by the FDA?

Biotrack Theophylline Quality Controls (K903924) received a 510(k) decision of Substantially Equivalent on September 17, 1990, 24 days after the submission was received.

What is the product code of K903924?

The FDA product code is LAW – Theophylline Control Materials, a Class I (low risk) device regulated under 21 CFR 862.3280.