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510(k) K981555

DIASCREEN REAGENT STRIPS by Chronimed, Inc. — Product Code LJX

K981555 is an FDA 510(k) premarket notification submitted by Chronimed, Inc. for the device "DIASCREEN REAGENT STRIPS". The FDA issued a decision of Substantially Equivalent on June 1, 1998. The device falls under product code LJX (Test, Urine Leukocyte), a Class I device regulated under 21 CFR 864.7675. Chronimed, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 1, 1998
Date Received
May 1, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Urine Leukocyte
Device Class
Class I
Regulation Number
864.7675
Review Panel
HE
Submission Type

Other clearances by Chronimed, Inc.

  • K010039 — QUICKTEK BLOOD GLUCOSE SYSTEM, QUICKTEK BLOOD GLUCOSE METER, QUICKTEK BLOOD GLUC (August 10, 2001)
  • K983432 — SUPREME II CONTROL SOLUTIONS (December 17, 1998)
  • K980573 — SENSOREX BLOOD GLUCOSE MONITORING SYSTEM (July 30, 1998)
  • K963544 — SUPREME II METER (February 20, 1997)

Other clearances for product code LJX

  • K231045 — Healgen URS Test Strips (June 16, 2023)
  • K063295 — ACON UTI URINARY TRACT INFECTION TEST STRIPS (October 12, 2007)
  • K000578 — SERIM LEUKOCYTE ESTERASE TEST STRIPS (May 5, 2000)
  • K971976 — DIASCREEN REAGENT STRIPS (June 17, 1997)
  • K873304 — CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES) (September 11, 1987)
  • K843727 — LEUKOSTIX REAGENT STRIPS FOR URINALYSIS (January 4, 1985)

FDA data resources