510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K851891Substantially Equivalent

Terran One Biomechanical Analysis Systems

Richard Scott Elliott, Salem OR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K851891 is the FDA 510(k) clearance record for TERRAN ONE BIOMECHANICAL ANALYSIS SYSTEMS, a class II device, cleared for Richard Scott Elliott on under FDA product code LOJ (Kit, Test,Alpha-Fetoprotein For Testicular Cancer). FDA records list one 510(k) clearance for Richard Scott Elliott. As of , FDA records show no recalls naming K851891.

Clearance record

Decision date
Received
(80 days to decision)
Product code
LOJ Kit, Test,Alpha-Fetoprotein For Testicular Cancer
Regulation
21 CFR 866.6010
Device class
Class II
Review panel
Immunology
Applicant
Richard Scott Elliott 1520 24th. St. NE, Salem OR
Third party review
No

Clearances, product code LOJ

Trailing 12 months

FDA records hold no clearances under product code LOJ in the trailing twelve months.

FDA records show no clearances under product code LOJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LOJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260