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510(k) K851891

TERRAN ONE BIOMECHANICAL ANALYSIS SYSTEMS by Richard Scott Elliott — Product Code LOJ

K851891 is an FDA 510(k) premarket notification submitted by Richard Scott Elliott for the device "TERRAN ONE BIOMECHANICAL ANALYSIS SYSTEMS". The FDA issued a decision of Substantially Equivalent on July 19, 1985. The device falls under product code LOJ (Kit, Test,Alpha-Fetoprotein For Testicular Cancer), a Class II device regulated under 21 CFR 866.6010.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 1985
Date Received
April 30, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Test,Alpha-Fetoprotein For Testicular Cancer
Device Class
Class II
Regulation Number
866.6010
Review Panel
IM
Submission Type

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  • K071597 — DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (June 4, 2008)
  • K023894 — ST AIA-PACK AFP ENZYME IMMUNOASSAY (December 17, 2002)
  • K020807 — AFP ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (October 1, 2002)
  • K020806 — ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAY (March 27, 2002)
  • K990138 — DSL ACTIVE AFP ELISA, MODEL DSL-10-8400 (June 21, 1999)

FDA data resources