Home / 510(k) Clearances / K922032

510(k) K922032

ENZIP URINARY MICROALBUMIN TEST by Diagnostic Specialties — Product Code JIR

K922032 is an FDA 510(k) premarket notification submitted by Diagnostic Specialties for the device "ENZIP URINARY MICROALBUMIN TEST". The FDA issued a decision of Substantially Equivalent on July 30, 1992. 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. Diagnostic Specialties has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 1992
Date Received
May 1, 1992
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 Diagnostic Specialties

  • K971458 — ENZIP IMMUNOTURBIDIMETRIC MICROALBUMIN ASSAY KIT (September 2, 1997)
  • K941001 — ENZIP IMMUNOTURBIDMETRIC FIBRINOGEN ASSAY KIT (August 30, 1994)
  • K930823 — PROTEIN-BOUND GLUCOSE ASSAYN KIT (August 19, 1993)
  • K831180 — PREGNA-CERT, SLIDE PREGNANCY TEST (May 27, 1983)
  • K823109 — GENERIC PREGNANCY TEST (November 10, 1982)
  • K813608 — POTASSIUM REAGENT SET (January 22, 1982)
  • K813412 — GLUCOSE ENZYME-COLOR REAGENT SET (December 31, 1981)

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