Skip to content

Haem-C Plus Blood Reference Controls

by Baker Instructions Corp. 510(k)

Active United States

510(k) K821956

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK821956 Date30 Jul 1982ClearedStatusActive

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  • Withdrawn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
JCN
Device Class
Class II
Regulation
21 CFR Part 864.8625
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

Other devices from Baker Instructions Corp.

See all devices from Baker Instructions Corp. →