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510(k) K963142

DCA 2000 + MICROALBUMIN/CREATININE ASSAY by Bayer Corp. — Product Code JIR

K963142 is an FDA 510(k) premarket notification submitted by Bayer Corp. for the device "DCA 2000 + MICROALBUMIN/CREATININE ASSAY". The FDA issued a decision of Substantially Equivalent on September 27, 1996. The device falls under product code JIR (Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)), a Class I device regulated under 21 CFR 862.1645. Bayer Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 1996
Date Received
August 13, 1996
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

Other clearances by Bayer Corp.

  • K024062 — ASCENSIA BREEZE BLOOD GLUCOSE METER (March 3, 2003)
  • K023944 — BAYER DIAGNOSTICS CLINITEST PREGNANCY TEST (February 11, 2003)
  • K024017 — BAYER ADVIA CENTAUR HER-2/NEU ASSAY (January 30, 2003)
  • 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)
  • K992257 — NEW MULTIPLES REAGENT STRIPS (November 24, 1999)
  • K991315 — MICROALBUSTIX REAGENT STRIPS (OTC) (November 12, 1999)
  • K983774 — UALB (January 28, 1999)

FDA data resources