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510(k) K790965

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 1979
Date Received
May 22, 1979
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

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  • 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)
  • K864530 — SERALYZER GLUCOSE (HK) REAGENT STRIPS,MODULE,CALI. (February 18, 1987)

Other clearances for product code CDM

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  • K880584 — URI-CHEM(R) GK,2,3,4C,5CN,6C,7C AND 8C (May 31, 1988)
  • K873366 — WAKO(TM) PRETEST 5A (January 21, 1988)
  • K852611 — TEST UROBILINOGEN IN URINE & LEUKOCYTES IN URINE (September 3, 1985)
  • K830340 — FITKIT I CHECKUP KIT (August 16, 1983)
  • K821799 — FITKIT I CHECKUP KIT (August 16, 1983)
  • K831623 — DIA STRIPS SYSTEM (July 28, 1983)