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510(k) K900875

RAICHEM(TM) SPIA(TM) TRANSFERRIN REAGENT by Reagents Applications, Inc. — Product Code DDG

K900875 is an FDA 510(k) premarket notification submitted by Reagents Applications, Inc. for the device "RAICHEM(TM) SPIA(TM) TRANSFERRIN REAGENT". The FDA issued a decision of Substantially Equivalent on March 6, 1990. The device falls under product code DDG (Transferrin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5880. Reagents Applications, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 1990
Date Received
February 26, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transferrin, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5880
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 DDG

  • K240987 — Access sTfR (July 3, 2024)
  • K190495 — Transferrin (March 16, 2020)
  • K182095 — Tina-quant Transferrin ver.2 (urine application) (November 5, 2018)
  • K120236 — TRANSFERRIN KIT FOR USE ON THE SPAPLUS (February 13, 2013)
  • K080634 — ACCESS STFR, ACCESS STFR CALIBRATORS, AND ACCESS STFR QC WITH MODELS, A32493, A3 (August 11, 2008)
  • K081299 — DIMENSION VISTA SYSTEM TRF FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEI (August 8, 2008)
  • K063086 — TRANSFERRIN, SPECICAL CALIBRATOR, SPECITROL AND SPECITROL HIGH CONTROLS (August 8, 2007)
  • K063766 — TRANSFERRIN TIA , CALIBRATOR SET, CONTROL-L,CONTROL-M,CONTROL-H, MODEL# KT-0105- (April 23, 2007)
  • K063663 — DIMENSION VISTA STFR FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL (March 21, 2007)
  • K063322 — DIMENSION VISTA TRF FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR PROTEIN 1 CONTR (January 24, 2007)

FDA data resources