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510(k) K894947

PLATELIA TOXO IGG KIT by Kallestad Diag, A Div. of Erbamont, Inc. — Product Code LGO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 1990
Date Received
August 3, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Leukocyte Typing
Device Class
Class I
Regulation Number
864.7675
Review Panel
HE
Submission Type

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

  • K910885 — QM300 CALIBRATOR G PACK (June 17, 1991)
  • K910886 — QM300 ANTISTREPTOLYSIN O (ASO) ANTIGEN PACK (June 17, 1991)
  • K910887 — QM300 CONTROL 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)
  • K894948 — PLATELIA TOXO IGM KIT (March 15, 1990)

Other clearances for product code LGO

  • K874544 — SNAP(R) CAMPYLOBACTER CULTURE IDENT DIAGNOSTIC KIT (August 12, 1988)
  • K791118 — HLA CONTROL SERA (August 3, 1979)
  • K761009 — LYMPHOCYTE TYPING, POSITIVE CONTROL (April 6, 1977)
  • K761008 — LYMPHOCYTE TYPING, NEGATIVE CONTROL (April 6, 1977)