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510(k) K821799

FITKIT I CHECKUP KIT by Patton, Boggs & Blow — Product Code CDM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 1983
Date Received
June 18, 1982
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 Patton, Boggs & Blow

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  • K943346 — MANUAL SURGICAL INST. AND ACC. TO KLS MINI OSTEOSYNTHESIS SYSTEM (October 4, 1994)
  • K943345 — MANUAL SURGICAL INST. AND ACC. TO KLS CHIN PLATE SYSTEM (October 4, 1994)
  • K823825 — NOSITE UV INTERIM SPECTACLES (February 24, 1983)

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  • K852611 — TEST UROBILINOGEN IN URINE & LEUKOCYTES IN URINE (September 3, 1985)
  • K830340 — FITKIT I CHECKUP KIT (August 16, 1983)
  • K831623 — DIA STRIPS SYSTEM (July 28, 1983)
  • K790965 — REAGENT STRIPS FOR URINALYSIS (June 28, 1979)