Control and Linearity

FDA 510(k) K910881 · Gds Diagnostics

Substantially Equivalent

510(k) numberK910881

Submission

Device name
Control and Linearity
Applicant
Gds Diagnostics
Elkhart, IN, US
Received
March 1, 1991
Decision date
September 13, 1991
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DKB – Calibrators, Drug Mixture
Device class
Class II (moderate risk)
Regulation
21 CFR 862.3200
Specialty
Clinical Toxicology

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Questions and answers

When was Control and Linearity cleared by the FDA?

Control and Linearity (K910881) received a 510(k) decision of Substantially Equivalent on September 13, 1991, 196 days after the submission was received.

What is the product code of K910881?

The FDA product code is DKB – Calibrators, Drug Mixture, a Class II (moderate risk) device regulated under 21 CFR 862.3200.