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510(k) K904497

CROMATEST RHEUMATOID DIAGNOSTIC/CRP LATEX TEST by Biotrax, Inc. — Product Code DCN

K904497 is an FDA 510(k) premarket notification submitted by Biotrax, Inc. for the device "CROMATEST RHEUMATOID DIAGNOSTIC/CRP LATEX TEST". The FDA issued a decision of Substantially Equivalent on November 1, 1990. The device falls under product code DCN (System, Test, C-Reactive Protein), a Class II device regulated under 21 CFR 866.5270. Biotrax, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 1, 1990
Date Received
October 2, 1990
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 Biotrax, Inc.

  • K904496 — CROMATEST SYPHILIS DIAGNOSTIC (July 24, 1991)
  • K904416 — CROATEST (R) RHEUMATOID DIAGNOSTIC (June 24, 1991)
  • K904498 — CROMATEST RHEUMATOID DIAGNOSTIC/RF LATEX TEST (October 29, 1990)

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