Diascreen Reagent Strips

FDA 510(k) K981555 · Chronimed, Inc.

Substantially Equivalent

510(k) numberK981555

Submission

Device name
Diascreen Reagent Strips
Applicant
Chronimed, Inc.
Edina, MN, US
Received
May 1, 1998
Decision date
June 1, 1998
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LJX – Test, Urine Leukocyte
Device class
Class I (low risk)
Regulation
21 CFR 864.7675
Specialty
Hematology

Other 510(k)s with product code LJX

510(k)DeviceApplicantDecision
K231045Healgen URS Test StripsLJX · Traditional Healgen Scientific,, LLC06/16/2023SE
K063295Acon Uti Urinary Tract Infection Test StripsLJX · Traditional ACON Laboratories, Inc.10/12/2007SE
K000578Serim Leukocyte Esterase Test StripsLJX · Traditional Serim Research Corp.05/05/2000SE
K971976Diascreen Reagent StripsLJX · Traditional Dia-Screen Corp.06/17/1997SE
K873304Clinitek Auto 2000 Reagent Cassette (Leukocytes)LJX · Traditional Miles Laboratories, Inc.09/11/1987SE
K843727Leukostix Reagent Strips for UrinalysisLJX · Traditional Miles Laboratories, Inc.01/04/1985SE

More from Miles Laboratories, Inc.

510(k)DeviceDecision
K010039Quicktek Blood Glucose System, Quicktek Blood Glucose Meter, Quicktek Blood Glucose…NBW · Traditional 08/10/2001SE
K983432Supreme II Control SolutionsJJX · Traditional 12/17/1998SE
K980573Sensorex Blood Glucose Monitoring SystemCGA · Traditional 07/30/1998SE
K963544Supreme II MeterCGA · Traditional 02/20/1997SE

Questions and answers

When was Diascreen Reagent Strips cleared by the FDA?

Diascreen Reagent Strips (K981555) received a 510(k) decision of Substantially Equivalent on June 1, 1998, 31 days after the submission was received.

What is the product code of K981555?

The FDA product code is LJX – Test, Urine Leukocyte, a Class I (low risk) device regulated under 21 CFR 864.7675.