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510(k) K960274

ORGENTEC MICRO-ALBUMIN PIN EIA ASSAY by Orgentec — Product Code JIR

K960274 is an FDA 510(k) premarket notification submitted by Orgentec for the device "ORGENTEC MICRO-ALBUMIN PIN EIA ASSAY". The FDA issued a decision of Substantially Equivalent on March 29, 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. Orgentec has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 1996
Date Received
January 19, 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 Orgentec

  • K954830 — ORGENTEC ANTI-SM(SMITH) PIN IMMUNO ASSAY (May 8, 1996)
  • K954831 — ORGENTEC ANTI-RNP/SM PIN IMMUNO ASSAY (May 8, 1996)
  • K954832 — ORGENTEC ANTI-SS-B(LA) PIN IMMUNO ASSAY (April 18, 1996)
  • K954815 — ORGENTEC ANTI-SS-A(RO) PIN IMMUNO ASSAY (April 18, 1996)
  • K954829 — ORGENTEC ANTI-JO-1 PIN IMMUNO ASSAY (April 18, 1996)
  • K954814 — ORGENTEC ANTI-SCL 70 PIN IMMUNO ASSAY (April 18, 1996)
  • K955134 — ORGENTEC ENASCREEN ELISA ASSAY (March 20, 1996)
  • K955133 — ORGENTEC ENASCREEN PIN IMMUNO ASSAY (March 20, 1996)
  • K953671 — ORGEN TEC ANTI-DSDNA ELISA ASSAY (November 9, 1995)

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