Theophylline Fpia Controls

FDA 510(k) K871589 · Sigma Chemical Co.

Substantially Equivalent

510(k) numberK871589

Submission

Device name
Theophylline Fpia Controls
Applicant
Sigma Chemical Co.
St. Louis, MO, US
Received
April 24, 1987
Decision date
June 17, 1987
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
K903924Biotrack Theophylline Quality ControlsLAW · Traditional Biotrack, Inc.09/17/1990SE

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Questions and answers

When was Theophylline Fpia Controls cleared by the FDA?

Theophylline Fpia Controls (K871589) received a 510(k) decision of Substantially Equivalent on June 17, 1987, 54 days after the submission was received.

What is the product code of K871589?

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