Home / 510(k) Clearances / K852611

510(k) K852611

TEST UROBILINOGEN IN URINE & LEUKOCYTES IN URINE by Miles Laboratories, Inc. — Product Code CDM

K852611 is an FDA 510(k) premarket notification submitted by Miles Laboratories, Inc. for the device "TEST UROBILINOGEN IN URINE & LEUKOCYTES IN URINE". The FDA issued a decision of Substantially Equivalent on September 3, 1985. The device falls under product code CDM (Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)), a Class I device regulated under 21 CFR 862.1785. Miles Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 3, 1985
Date Received
June 19, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)
Device Class
Class I
Regulation Number
862.1785
Review Panel
CH
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 CDM

  • K052719 — URITEST 10 URINALYSIS REAGENT STRIPS (December 5, 2006)
  • K061559 — ACON URINALYSIS REAGENT STRIPS (August 11, 2006)
  • K880584 — URI-CHEM(R) GK,2,3,4C,5CN,6C,7C AND 8C (May 31, 1988)
  • K873366 — WAKO(TM) PRETEST 5A (January 21, 1988)
  • K830340 — FITKIT I CHECKUP KIT (August 16, 1983)
  • K821799 — FITKIT I CHECKUP KIT (August 16, 1983)
  • K831623 — DIA STRIPS SYSTEM (July 28, 1983)
  • K790965 — REAGENT STRIPS FOR URINALYSIS (June 28, 1979)

FDA data resources