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510(k) K831498

URI-TEST 3, INLAB REAGENT STRIPS-URINAL by Laprol Scientific, Inc. — Product Code JIL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 1983
Date Received
May 11, 1983
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 Laprol Scientific, Inc.

  • K831499 — GLUCOSE 3, INLAB REAGENT STRIPS-URINALY (June 17, 1983)
  • K822709 — URITEST 9, INLAB REAGENT STRIPS URINALY (January 28, 1983)

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