Skip to content

Discrete Photometric Chemistry Analyzer

by Hamilton Co. 510(k)

Active United States

510(k) K943493

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK943493 Date30 Jan 1995ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

1 recall · FDA

    • Terminated Z-0103-2012 FDA Unclassified (pre-2012) initiated 26 Sep 2011

    Certain lots of syringes have caused an increase in error message "DIS541", which indicates "improper dispensation".

Specification

510(k)

510(k) Number
FDA Product Code
JJE
Device Class
Class I
Regulation
21 CFR Part 862.2160
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Other devices from Hamilton Co.

See all devices from Hamilton Co. →