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510(k) K001810

URISITE URINE COLLECTION KIT FOR MICROALBUMIN/CREATININE TESTING by Flexsite Diagnostics, Inc. — Product Code JIR

K001810 is an FDA 510(k) premarket notification submitted by Flexsite Diagnostics, Inc. for the device "URISITE URINE COLLECTION KIT FOR MICROALBUMIN/CREATININE TESTING". The FDA issued a decision of Substantially Equivalent on August 14, 2000. 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. Flexsite Diagnostics, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 2000
Date Received
June 15, 2000
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 Flexsite Diagnostics, Inc.

  • K971919 — EZCHEK/HBA BLOOD COLLECTION KIT (September 5, 1997)

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)
  • 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)
  • K972960 — HEALTH CHECK URI-TEST PROTEIN IN URINE (October 7, 1998)

FDA data resources