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Eon 100 Chemistry Analyzer with Ise, Model 77105, Bicarbonate Reagent, Model 77475

by Vital Diagnostics (Manufacturing) Ptyltd

510(k) K100060

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK100060 Date15 Dec 2010ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
KHS
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 862.1160
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

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