Skip to content

Alkaline Phosphatase Test (Alp) Item No. 65651

by Em Diagnostic Systems, Inc. 510(k)

Active United States

510(k) K884549

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK884549 Date10 Nov 1988ClearedStatusActive

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  • Withdrawn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
CJE
Device Class
Class II
Regulation
21 CFR Part 862.1050
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Other devices from Em Diagnostic Systems, Inc.

See all devices from Em Diagnostic Systems, Inc. →