Urine Calibrator

FDA 510(k) K940935 · Diagnostic Reagents, Inc.

Substantially Equivalent

510(k) numberK940935

Submission

Device name
Urine Calibrator
Applicant
Diagnostic Reagents, Inc.
Mountain View, CA, US
Received
February 25, 1994
Decision date
July 6, 1994
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

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 Urine Calibrator cleared by the FDA?

Urine Calibrator (K940935) received a 510(k) decision of Substantially Equivalent on July 6, 1994, 131 days after the submission was received.

What is the product code of K940935?

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