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510(k) K000578

SERIM LEUKOCYTE ESTERASE TEST STRIPS by Serim Research Corp. — Product Code LJX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 2000
Date Received
February 22, 2000
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

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  • K873304 — CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES) (September 11, 1987)
  • K843727 — LEUKOSTIX REAGENT STRIPS FOR URINALYSIS (January 4, 1985)