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510(k) K971976

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

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

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  • 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)