Mini S.F.T. (Urine Preservative)

FDA 510(k) K943466 · Cambridge Diagnostic Products, Inc.

Substantially Equivalent

510(k) numberK943466

Submission

Device name
Mini S.F.T. (Urine Preservative)
Applicant
Cambridge Diagnostic Products, Inc.
Ft. Lauderdale, FL, US
Received
June 15, 1994
Decision date
May 24, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
LXG – Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
Device class
Class I (low risk)
Regulation
21 CFR 862.2050
Specialty
Clinical Chemistry

Other 510(k)s with product code LXG

510(k)DeviceApplicantDecision
K021927Platelet Concentrate Separation Kit for Celsep Centrifuge SystemLXG · Special Biomet, Inc.07/12/2002SE
K896802Magnet PadLXG · Traditional Westmark, Sterile Packing Systems, Inc. (Sps)12/27/1989SE

Questions and answers

When was Mini S.F.T. (Urine Preservative) cleared by the FDA?

Mini S.F.T. (Urine Preservative) (K943466) received a 510(k) decision of Substantially Equivalent on May 24, 1995, 343 days after the submission was received.

What is the product code of K943466?

The FDA product code is LXG – Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use, a Class I (low risk) device regulated under 21 CFR 862.2050.