Skip to content

Serodot Toxoplasma Igg Test Kit

by Disease Detection International, Inc. 510(k)

Active United States

510(k) K875363

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK875363 Date21 Apr 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  • Withdrawn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 10 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
LGD
Device Class
Class II
Regulation
21 CFR Part 866.3780
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

Other devices from Disease Detection International, Inc.

See all devices from Disease Detection International, Inc. →