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Cx(Tm) Cannabinoid 50NG(THC5) Reagent/Synchron Cx Sys

by Beckman Instruments, Inc. 510(k)

Active United States

510(k) K944086

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK944086 Date29 Dec 1994ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
LDJ
Device Class
Class II
Regulation
21 CFR Part 862.3870
Advisory Committee
Clinical Toxicology
FDA Decision
SESE Substantially Equivalent

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