Home / 510(k) Clearances / K885001

510(k) K885001

QM300 PCR ANTIBODY PACK by Kallestad Diag, A Div. of Erbamont, Inc. — Product Code DCN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 1988
Date Received
December 1, 1988
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 Kallestad Diag, A Div. of Erbamont, Inc.

  • K910885 — QM300 CALIBRATOR G PACK (June 17, 1991)
  • K910887 — QM300 CONTROL G PACK (June 17, 1991)
  • K910886 — QM300 ANTISTREPTOLYSIN O (ASO) ANTIGEN PACK (June 17, 1991)
  • K904725 — CHLAMYDIA SYSTEM SOFTWARE (CSS) (January 14, 1991)
  • K902253 — PATHFINDER(TM) CHLAMYDIA MICROPLATE KIT (July 26, 1990)
  • K902462 — MODIFIED QM300 RHEUMATOID FACTOR TEST (June 21, 1990)
  • K900010 — NDS CORTISOL TEST KIT AND NDS CORTISOL CALIBRATOR (April 3, 1990)
  • K900009 — NDS THEOPHYLLINE TEST KIT & NDS TDM CALIBRATOR SET (March 29, 1990)
  • K897072 — NDS THYROXINE TEST KIT & NDS THYROXINE CALIBRATOR (March 29, 1990)
  • K894947 — PLATELIA TOXO IGG KIT (March 23, 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)