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510(k) K841265

TAGO DIFFU-GEN C-REACTIVE PROTEIN by Tago, Inc. — Product Code DCN

K841265 is an FDA 510(k) premarket notification submitted by Tago, Inc. for the device "TAGO DIFFU-GEN C-REACTIVE PROTEIN". The FDA issued a decision of Substantially Equivalent on May 22, 1984. The device falls under product code DCN (System, Test, C-Reactive Protein), a Class II device regulated under 21 CFR 866.5270. Tago, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 1984
Date Received
March 26, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, C-Reactive Protein
Device Class
Class II
Regulation Number
866.5270
Review Panel
IM
Submission Type

Other clearances by Tago, Inc.

  • K841734 — TAGO FIFFU-GEN, OROSOMUCOID (June 1, 1984)
  • K834218 — DIFFU-GEN APOLIPOPROTEIN A-I RADIAL - (May 11, 1984)
  • K840404 — DIFFU-GEN HAPTOGLOBIN RADIAL IMMUNO (March 9, 1984)
  • K833129 — TAGO DIFFU-GEN-APOLIPOPROTEIN B-100 (November 21, 1983)
  • K830611 — RA SCREENING TEST (March 24, 1983)
  • K830531 — MONO SCREENING TEST (March 17, 1983)
  • K830156 — HCG SCREENING TEST (February 9, 1983)

Other clearances for product code DCN

  • K232624 — CardioPhase® hsCRP (November 27, 2023)
  • K221119 — RCRP Flex reagent cartridge (March 17, 2023)
  • K192072 — Tina-quant C-Reactive Protein IV (February 21, 2020)
  • K180099 — Optilite High Sensitivity C-Reactive Protein Kit (October 12, 2018)
  • K172868 — Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optil (February 28, 2018)
  • K171498 — MSD CRP Assay Kit and MESO SECTOR S 700 Instrument (January 12, 2018)
  • K161982 — C-Reactive Protein Kit for use on SPAPLUS (April 5, 2017)
  • K113809 — HITACHI CLINICAL ANALYZER S TEST REGENT CARTRIDGE C-REACTIVE PROTEIN (CRP) (August 17, 2012)
  • K091052 — PICCOLO C-REACTIVE PROTEIN (CRP) TEST SYSTEM (January 15, 2010)
  • K083444 — C-REACTIVE PROTEIN (LATEX) (March 18, 2009)

FDA data resources