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510(k) K902204

STANBIO CSF/URINE TOTAL PROTEIN TEST SET by Stanbio Laboratory — Product Code JIR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 1990
Date Received
May 16, 1990
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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  • K050266 — DIRECT BILIRUBIN LIQUICOLOR AND TOTAL BILIRUBIN LIQUICOLOR (June 30, 2005)
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  • K042169 — STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZER (March 14, 2005)
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  • K032936 — DIRECT LDL CHOLESTEROL LIQUID COLOR AND STANBIO DIRECT HDL/LDL CHOLESTEROL CALIB (March 12, 2004)
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  • K032482 — STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM (October 24, 2003)
  • K020378 — QUPID PLUS E.R. (June 21, 2002)

Other clearances for product code JIR

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  • 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)