Home / 510(k) Clearances / K831362

510(k) K831362

TESTCORP CRP by Catheter Technology Corp. — Product Code DCN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 1983
Date Received
April 26, 1983
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 Catheter Technology Corp.

  • K880571 — CATH-TECH PORT IMPLANTABLE VASCULAR ACCESS SYSTEM (March 4, 1988)
  • K871080 — PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (August 12, 1987)
  • K871998 — GROSHONG CV CATHETER REPAIR KIT (June 24, 1987)
  • K860256 — BRAWN AND GROSHONG CATHETERS (March 28, 1986)
  • K842577 — CATH-TECH POLYURETHANE UMBILICAL VESS (March 13, 1985)
  • K842147 — CATH-TECH CHOLANGIOGRAPHY CATHETER (October 2, 1984)
  • K840339 — UMBILICAL VESSEL CATHETER (July 25, 1984)
  • K831386 — GROSHONG CATHETER, LONG TERM TYPE (October 14, 1983)
  • K831366 — TESTCORP PREG (June 2, 1983)
  • K831361 — BETA-PREG (June 2, 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)