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510(k) K903123

RAICHEM(TM) SPIA(TM) MICROALBULMIN REAGENT by Reagents Applications, Inc. — Product Code JIQ

K903123 is an FDA 510(k) premarket notification submitted by Reagents Applications, Inc. for the device "RAICHEM(TM) SPIA(TM) MICROALBULMIN REAGENT". The FDA issued a decision of Substantially Equivalent on September 14, 1990. 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. Reagents Applications, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 1990
Date Received
July 16, 1990
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 Reagents Applications, Inc.

  • K982056 — RAICHEM CO2 REAGENT (June 24, 1998)
  • K972853 — CHOLESTEROL RAPID LIQUID REAGENT (September 24, 1997)
  • K922904 — RAI-TROL FRUCTOSAMINE SERUM CONTROLS I AND II (July 30, 1992)
  • K915191 — RAI-TROL ELEVATED LIPIDS CONTROL (December 18, 1991)
  • K913398 — RAICHEM(TM) CREATINE KINASE-MB REAGENT (September 25, 1991)
  • K911899 — RAICHEM SPIA C4 REAGENT (May 9, 1991)
  • K911900 — RAICHEM SPIA C3 REAGENT (May 9, 1991)
  • K911898 — RAICHEM(TM) SPIA(TM) HAPTOGLOBIN REAGENT (May 8, 1991)
  • K905085 — RAICHEM GGT REAGENT (December 20, 1990)
  • K905084 — RAICHEM CREATINE KINASE REAGENT, OPTIMIZED UV (December 20, 1990)

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)
  • K971458 — ENZIP IMMUNOTURBIDIMETRIC MICROALBUMIN ASSAY KIT (September 2, 1997)
  • 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)
  • K902216 — WAKO(TM) MICRO-ALBUMIN (June 18, 1990)
  • K895883 — BECKMAN MA MICROALBUMIN REAGENT KIT (December 27, 1989)

FDA data resources