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510(k) K860679

IMMUNOCHEMICAL ASSAY OF C-REACTIVE PROTEIN by Orion Corp. — Product Code DCN

K860679 is an FDA 510(k) premarket notification submitted by Orion Corp. for the device "IMMUNOCHEMICAL ASSAY OF C-REACTIVE PROTEIN". The FDA issued a decision of SN on August 4, 1986. The device falls under product code DCN (System, Test, C-Reactive Protein), a Class II device regulated under 21 CFR 866.5270. Orion Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
August 4, 1986
Date Received
February 25, 1986
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 Orion Corp.

  • K912391 — RUBALEX, MODIFICATION (May 4, 1992)
  • K901637 — RESUBMITTED MODIFIED RUBALEX (April 26, 1990)
  • K884650 — RESUBMITTED SCANORA (March 16, 1989)
  • K890199 — DENTOCULT SM-STRIP MUTANS (March 2, 1989)
  • K881505 — MAMEX DC MG11 (June 10, 1988)
  • K881506 — MAMEX DC MAG MG12 (June 10, 1988)
  • K874040 — MAMEX DC S SL10/MG14 (November 23, 1987)
  • K872744 — MODIFIED CHLAMYSET ANTIGEN (September 22, 1987)
  • K872301 — DENTOCULT-SM CULTURE-PADDLE (September 11, 1987)
  • K864457 — CHLAMYSET ANTIBODY EIA (September 11, 1987)

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