Theophylline Assay to the Centrifichem

FDA 510(k) K780441 · Syva Co.

Substantially Equivalent

510(k) numberK780441

Submission

Device name
Theophylline Assay to the Centrifichem
Applicant
Syva Co.
Mchenry, IL, US
Received
March 20, 1978
Decision date
April 12, 1978
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
K891761GDS Enzymatic Theophylline ReagentLCY · Traditional Gds Diagnostics05/16/1989SE
K780442Theophylline Assay to the GemsaecLCY · Traditional Syva Co.04/12/1978SE

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Questions and answers

When was Theophylline Assay to the Centrifichem cleared by the FDA?

Theophylline Assay to the Centrifichem (K780441) received a 510(k) decision of Substantially Equivalent on April 12, 1978, 23 days after the submission was received.

What is the product code of K780441?

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