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510(k) K943008

BIOSCAN REAGENT STRIPS by Genesis Labs, Inc. — Product Code JJB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 1994
Date Received
June 24, 1994
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 Genesis Labs, Inc.

  • K961375 — DIA SCREEN 10 WAY REAGENT STRIPS (June 18, 1996)
  • K952971 — DIA SCREEN REAGENT STRIPS (August 11, 1995)

Other clearances for product code JJB

  • K943436 — URINE REAGENT STRIPS-8 PARAMETERS (April 24, 1995)
  • K873553 — WAKO(TM) PRETEST 8A (September 22, 1987)
  • K862806 — URINE DIAGNOSTIC REAGENT STRIPS (December 4, 1986)
  • K833521 — REAGENT TESTS STRIP COMBINATIONS (January 11, 1984)