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510(k) K971976

DIASCREEN REAGENT STRIPS by Dia-Screen Corp. — Product Code LJX

K971976 is an FDA 510(k) premarket notification submitted by Dia-Screen Corp. for the device "DIASCREEN REAGENT STRIPS". The FDA issued a decision of Substantially Equivalent on June 17, 1997. The device falls under product code LJX (Test, Urine Leukocyte), a Class I device regulated under 21 CFR 864.7675.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 1997
Date Received
May 29, 1997
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 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)
  • K981555 — DIASCREEN REAGENT STRIPS (June 1, 1998)
  • K873304 — CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES) (September 11, 1987)
  • K843727 — LEUKOSTIX REAGENT STRIPS FOR URINALYSIS (January 4, 1985)

FDA data resources