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510(k) K894418

RAICHEM(TM) SPIA(TM) IGA REAGENTS by Reagents Applications, Inc. — Product Code CZP

K894418 is an FDA 510(k) premarket notification submitted by Reagents Applications, Inc. for the device "RAICHEM(TM) SPIA(TM) IGA REAGENTS". The FDA issued a decision of Substantially Equivalent on August 2, 1989. The device falls under product code CZP (Iga, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5510. Reagents Applications, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 1989
Date Received
July 17, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Iga, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5510
Review Panel
IM
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 CZP

  • K193525 — Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Im (June 26, 2020)
  • K060130 — IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENT (February 13, 2006)
  • K040435 — ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2 (March 10, 2004)
  • K024038 — N LATEX IGA (February 13, 2003)
  • K993927 — WAKO IGA II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOGLOBULIN STANDRAD (January 14, 2000)
  • K983359 — IGA (November 4, 1998)
  • K962200 — QUANTEX IGA (September 25, 1996)
  • K955794 — IGA IMMUNOTURBIDIMETRIC & CALIBRATOR (April 5, 1996)
  • K955907 — BOEHRINGER MANNHEIM IGA ASSAY (February 9, 1996)
  • K952309 — N LATEX IGA (June 20, 1995)

FDA data resources