Home / 510(k) Clearances / K871339

510(k) K871339

KALLESTAD QM300 PROTEIN ANALYSIS SYSTEM by Kallestad Diag, A Div. of Erbamont, Inc. — Product Code JQP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 1987
Date Received
April 2, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calculator/Data Processing Module, For Clinical Use
Device Class
Class I
Regulation Number
862.2100
Review Panel
CH
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 JQP

  • K113007 — BIONIME DIABETES MANAGEMENT SYSTEM VI.0 (February 27, 2012)
  • K983468 — FASTTAKE ADAPTER, MODEL # P/N 020-072-01 (December 17, 1998)
  • K964460 — THE ROBOLITE (January 24, 1997)
  • K953652 — PRENVAL I (September 15, 1995)
  • K934111 — MR7000 WITH TIME MANAGER SOFTWARE (TMS) (November 2, 1994)
  • K923316 — EXPRESSO CARTRIDGE (February 23, 1993)
  • K893838 — MODIFIED MODEL 570 CLINICAL CHEMISTRY ANALYZER (August 31, 1989)
  • K892060 — CYBERLAB HIGH VOLUME DRUG TESTING SYSTEM (August 10, 1989)
  • K885292 — COBAS MFC (March 22, 1989)
  • K881194 — RIA-QUICK (June 1, 1988)