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510(k) K862806

URINE DIAGNOSTIC REAGENT STRIPS by Amatech International, Inc. — Product Code JJB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 1986
Date Received
July 23, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)
Device Class
Class I
Regulation Number
862.1115
Review Panel
CH
Submission Type

Other clearances by Amatech International, Inc.

  • K875049 — MD STRIPS BG (August 23, 1988)
  • K872704 — AMASTIM 2000 (January 22, 1988)

Other clearances for product code JJB

  • K943436 — URINE REAGENT STRIPS-8 PARAMETERS (April 24, 1995)
  • K943008 — BIOSCAN REAGENT STRIPS (August 8, 1994)
  • K873553 — WAKO(TM) PRETEST 8A (September 22, 1987)
  • K833521 — REAGENT TESTS STRIP COMBINATIONS (January 11, 1984)