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Ilex Prompt Clinical Chemistry Analyer

by Ilex Corp. 510(k)

Active United States

510(k) K853068

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK853068 Date31 Oct 1985ClearedStatusActive

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  • Withdrawn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
CEM
Device Class
Class II
Regulation
21 CFR Part 862.1600
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

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