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510(k) K231045

Healgen URS Test Strips by Healgen Scientific, LLC — Product Code LJX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 2023
Date Received
April 12, 2023
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

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Other clearances for product code LJX

  • K063295 — ACON UTI URINARY TRACT INFECTION TEST STRIPS (October 12, 2007)
  • K000578 — SERIM LEUKOCYTE ESTERASE TEST STRIPS (May 5, 2000)
  • K981555 — DIASCREEN REAGENT STRIPS (June 1, 1998)
  • 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)