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510(k) K830340

FITKIT I CHECKUP KIT by Boditestor — Product Code CDM

K830340 is an FDA 510(k) premarket notification submitted by Boditestor for the device "FITKIT I CHECKUP KIT". The FDA issued a decision of Substantially Equivalent on August 16, 1983. The device falls under product code CDM (Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)), a Class I device regulated under 21 CFR 862.1785.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 1983
Date Received
February 2, 1983
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 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)
  • K852611 — TEST UROBILINOGEN IN URINE & LEUKOCYTES IN URINE (September 3, 1985)
  • 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