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510(k) K843727

LEUKOSTIX REAGENT STRIPS FOR URINALYSIS by Miles Laboratories, Inc. — Product Code LJX

K843727 is an FDA 510(k) premarket notification submitted by Miles Laboratories, Inc. for the device "LEUKOSTIX REAGENT STRIPS FOR URINALYSIS". The FDA issued a decision of Substantially Equivalent on January 4, 1985. The device falls under product code LJX (Test, Urine Leukocyte), a Class I device regulated under 21 CFR 864.7675. Miles Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 4, 1985
Date Received
September 24, 1984
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 Miles Laboratories, Inc.

  • K880605 — LABELING CHANGE FOR CUTTER PUREFLO PLUS IV FILTER (May 26, 1988)
  • K874909 — MICRO-BUMINTEST REAGENT TABLETS (April 28, 1988)
  • K875079 — MODIFIED SERALYZER ALT/SGPT REAG. STRIPS & MODULE (April 5, 1988)
  • K871835 — GLUCOMETER QC BLOOD METER, AMES GLUCO SYSTEM PRINT (December 22, 1987)
  • K872120 — SERALYZER III BLOOD CHEMISTRY ANALYZER (October 28, 1987)
  • K873304 — CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES) (September 11, 1987)
  • K872634 — CUTTER PUREFLO PLUS IV FILTER (August 4, 1987)
  • K870214 — MODIFIED SALTEX REAGENT STRIPS (June 29, 1987)
  • K870752 — SERALYZER LDH/TOTAL BILIRUBIN/TRIGLYCERIDES STRIPS (April 14, 1987)
  • K865053 — SERA-TEK MICROSOMAL ANTIBODY TEST (February 18, 1987)

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)
  • K971976 — DIASCREEN REAGENT STRIPS (June 17, 1997)
  • K873304 — CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES) (September 11, 1987)

FDA data resources