Home / 510(k) Clearances / K971458

510(k) K971458

ENZIP IMMUNOTURBIDIMETRIC MICROALBUMIN ASSAY KIT by Diagnostic Specialties — Product Code JIQ

K971458 is an FDA 510(k) premarket notification submitted by Diagnostic Specialties for the device "ENZIP IMMUNOTURBIDIMETRIC MICROALBUMIN ASSAY KIT". The FDA issued a decision of Substantially Equivalent on September 2, 1997. The device falls under product code JIQ (Turbidimetric 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
September 2, 1997
Date Received
April 22, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Turbidimetric 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

  • K941001 — ENZIP IMMUNOTURBIDMETRIC FIBRINOGEN ASSAY KIT (August 30, 1994)
  • K930823 — PROTEIN-BOUND GLUCOSE ASSAYN KIT (August 19, 1993)
  • K922032 — ENZIP URINARY MICROALBUMIN TEST (July 30, 1992)
  • 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 JIQ

  • K141925 — TOTAL PROTEIN URINE/CSF GEN.3 (December 9, 2014)
  • K013643 — AUSAM TOTAL ALBUMIN ASSAY (August 14, 2003)
  • K991800 — HEMOCHEK URINE COLLECTION KIT (September 24, 1999)
  • K965035 — IMMAGE IMMUNOCHEMISTRY SYSTEM MICROALBUMIN (MA) REAGENT (April 17, 1997)
  • K944664 — WAKO MICRO-ALBUMIN B/WAKO MICRO ALBUMIN CALIBRATOR (February 7, 1995)
  • K936202 — URINARY ALBUMIN TEST PACK (May 9, 1994)
  • K935662 — SYNERMED IR 500 CHEMISTRY ANALYZER (April 26, 1994)
  • K903123 — RAICHEM(TM) SPIA(TM) MICROALBULMIN REAGENT (September 14, 1990)
  • K902216 — WAKO(TM) MICRO-ALBUMIN (June 18, 1990)
  • K895883 — BECKMAN MA MICROALBUMIN REAGENT KIT (December 27, 1989)

FDA data resources