Skip to content

Cedia Dau Multi-Dr Calibrator/Pri, Sec, Inter, High

by Boehringer Mannheim Corp. 510(k)

Active United States

510(k) K954608

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK954608 Date26 Dec 1995ClearedStatusActive

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  • Withdrawn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 9 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
DKB
Device Class
Class II
Regulation
21 CFR Part 862.3200
Advisory Committee
Clinical Toxicology
FDA Decision
SESE Substantially Equivalent

Other devices from Boehringer Mannheim Corp.

See all devices from Boehringer Mannheim Corp. →