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510(k) K850690

ANTISERUM TO HUMAN APOLIPOPROTEIN B by Kent Laboratories, Inc. — Product Code MSJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 1, 1985
Date Received
February 21, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apolipoproteins
Device Class
Class I
Regulation Number
862.1475
Review Panel
CH
Submission Type

Other clearances by Kent Laboratories, Inc.

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  • K951967 — HUMAN C1 INACTIVATOR OR C-1 ESTERASE INHIBITOR RADIAL IMMUNODIFFUSION KIT (May 30, 1995)
  • K951968 — HUMAN C1Q RADIAL IMMUNODIFFUSION KIT (May 30, 1995)
  • K950102 — HUMAN C-5 RADIAL IMMUNODIFFUSION KIT (April 10, 1995)
  • K850683 — 72 DETERM. SIZE RADIAL IMMUNODIFFUSION TEST ALPHA2 (November 27, 1985)
  • K850682 — 72 DETERM. SIZE RADIAL IMMUNO. TEST HUMAN CERULOPL (November 25, 1985)
  • K850686 — ANTISERUM TO HUMAN PREALBUMIN (November 1, 1985)
  • K850691 — ANTISERUM TO HUMAN APOLIPOPROTEIN A-I (November 1, 1985)
  • K831961 — IMMUNODIFFUSION TEST HUMAN ANTITHROMBIN (August 11, 1983)
  • K831960 — TEST FOR HUMAN ALPHA ONE ACID GLYCO- (July 19, 1983)

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  • K970314 — SYNCHRON LX SYSTEMS APOLIPOPROTEIN (APOA AND APOB) REAGENTS (April 21, 1997)
  • K964010 — IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN A-1 REAGENT (APA)/ IMMAGE IMMUNOCHE (February 10, 1997)
  • K931777 — APO A-1 CHEMILUMINESCENCE ASSAY (August 16, 1993)
  • K925702 — NICHOLS APO B CHEMILUMINESCENCE ASSAY (December 23, 1992)
  • K923087 — IL TEST APOLIPOPROTEIN A1 (October 26, 1992)