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510(k) K952971

DIA SCREEN REAGENT STRIPS by Genesis Labs, Inc. — Product Code JIL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 1995
Date Received
June 27, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
Device Class
Class II
Regulation Number
862.1340
Review Panel
CH
Submission Type

Other clearances by Genesis Labs, Inc.

  • K961375 — DIA SCREEN 10 WAY REAGENT STRIPS (June 18, 1996)
  • K943008 — BIOSCAN REAGENT STRIPS (August 8, 1994)

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