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510(k) K822709

URITEST 9, INLAB REAGENT STRIPS URINALY by Laprol Scientific, Inc. — Product Code JMA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 1983
Date Received
September 7, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)
Device Class
Class I
Regulation Number
862.1095
Review Panel
CH
Submission Type

Other clearances by Laprol Scientific, Inc.

  • K831498 — URI-TEST 3, INLAB REAGENT STRIPS-URINAL (June 22, 1983)
  • K831499 — GLUCOSE 3, INLAB REAGENT STRIPS-URINALY (June 17, 1983)

Other clearances for product code JMA

  • K931523 — QUANTIMETRIX C-CLEAR(TM) (June 25, 1993)
  • K830978 — HELENA BIOSTRIP A (May 13, 1983)