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510(k) K872599

QM300 C4 ANTIBODY PACK by Kallestad Diag, A Div. of Erbamont, Inc. — Product Code DBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 1987
Date Received
July 2, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Complement C4, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5240
Review Panel
IM
Submission Type

Other clearances by Kallestad Diag, A Div. of Erbamont, Inc.

  • K910886 — QM300 ANTISTREPTOLYSIN O (ASO) ANTIGEN PACK (June 17, 1991)
  • K910887 — QM300 CONTROL G PACK (June 17, 1991)
  • K910885 — QM300 CALIBRATOR G 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)
  • K897072 — NDS THYROXINE TEST KIT & NDS THYROXINE CALIBRATOR (March 29, 1990)
  • K900009 — NDS THEOPHYLLINE TEST KIT & NDS TDM CALIBRATOR SET (March 29, 1990)
  • K894947 — PLATELIA TOXO IGG KIT (March 23, 1990)

Other clearances for product code DBI

  • K100455 — SPAPLUS ANALYZER (September 3, 2010)
  • K012359 — TINA-QUANT COMPLEMENT C4 TEST SYSTEM (November 29, 2001)
  • K010325 — WAKO AUTOKIT C4 (June 25, 2001)
  • K000468 — RANDOX COMPLEMENT C4 (March 27, 2000)
  • K994293 — DIMENSION C4 FLEX REAGENT CARTRIDGE (March 1, 2000)
  • K981785 — C4 MININEPH ANTISERUM (December 20, 1999)
  • K993481 — K-ASSAY C4 (November 29, 1999)
  • K983356 — C4 (November 4, 1998)
  • K964300 — N-ASSAY TIA MULTI V-NL (July 14, 1997)
  • K964297 — N-ASSAY TIA C4 TEST KIT (July 14, 1997)