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510(k) K992257

NEW MULTIPLES REAGENT STRIPS by Bayer Corp. — Product Code JIR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 1999
Date Received
July 6, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
Device Class
Class I
Regulation Number
862.1645
Review Panel
CH
Submission Type

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  • K024234 — ASCENSIA GLUCOFACTS; ASCENSIA GLUCOFACTS PROFESSIONAL (January 23, 2003)
  • K022288 — COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED (December 17, 2002)
  • K023584 — ASCENSIA DEX 2 DIABETES CARE SYSTEM (November 20, 2002)
  • K020828 — CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEM (July 24, 2002)
  • K021428 — CLINITEK ATLAS PRO 12 REAGENT PAK SYSTEM (July 5, 2002)
  • K020806 — ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAY (March 27, 2002)
  • K013568 — CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (December 21, 2001)

Other clearances for product code JIR

  • K222921 — Minuteful-kidney test (September 8, 2023)
  • K210069 — Minuteful - kidney test (July 6, 2022)
  • K150330 — Mission Urinalysis Reagent Strips (Microalbumin/Creatinine) (April 30, 2015)
  • K061419 — TECO MICROALBUMIN 2-1 COMBO STRIPS (January 26, 2007)
  • K022538 — IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25 (August 23, 2002)
  • K001810 — URISITE URINE COLLECTION KIT FOR MICROALBUMIN/CREATININE TESTING (August 14, 2000)
  • K994035 — IMMUNODIP URINARY ALBUMIN SCREEN, MODEL 790-01, 790-15 (February 1, 2000)
  • K991315 — MICROALBUSTIX REAGENT STRIPS (OTC) (November 12, 1999)
  • K983774 — UALB (January 28, 1999)
  • K972960 — HEALTH CHECK URI-TEST PROTEIN IN URINE (October 7, 1998)