GDS Enzymatic Theophylline Reagent

FDA 510(k) K891761 · Gds Diagnostics

Substantially Equivalent

510(k) numberK891761

Submission

Device name
GDS Enzymatic Theophylline Reagent
Applicant
Gds Diagnostics
Elkhart, IN, US
Received
March 24, 1989
Decision date
May 16, 1989
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
LCY – U.V. Spectrometry, Theophylline
Device class
Class II (moderate risk)
Regulation
21 CFR 862.3880
Specialty
Clinical Toxicology

Other 510(k)s with product code LCY

510(k)DeviceApplicantDecision
K780442Theophylline Assay to the GemsaecLCY · Traditional Syva Co.04/12/1978SE
K780441Theophylline Assay to the CentrifichemLCY · Traditional Syva Co.04/12/1978SE

More from Syva Co.

510(k)DeviceDecision
K931257AcetasiteLDP · Traditional 07/08/1993SE
K910881Control and LinearityDKB · Traditional 09/13/1991SE
K910108GDS Enzymatic B-Hydroxybutyrate Reagent ModifiedJIN · Traditional 03/04/1991SE

Questions and answers

When was GDS Enzymatic Theophylline Reagent cleared by the FDA?

GDS Enzymatic Theophylline Reagent (K891761) received a 510(k) decision of Substantially Equivalent on May 16, 1989, 53 days after the submission was received.

What is the product code of K891761?

The FDA product code is LCY – U.V. Spectrometry, Theophylline, a Class II (moderate risk) device regulated under 21 CFR 862.3880.