Precimat(R) Transferrin

by Boehringer Mannheim Corp. 510(k)

Active United States

510(k) K871022

Regulatory status

as of 28 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK871022	Date14 May 1987Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
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: K871022
FDA Product Code: DDG

Device Class: Class II
Regulation: 21 CFR Part 866.5880
Advisory Committee: Immunology
FDA Decision: SESE Substantially Equivalent

Other devices from Boehringer Mannheim Corp.

Unimeter 330K

Class II
Precinorm Hdl Cholesterol Control Material for Ref

Class I
Precimat Glycerol

Class I
Roche Diagnostics, Boehringer Mannheim Corporation Liquid Direct Bilirubin Reagent, Catalog Number 1877844

Class II
Stattek Bun

Class II
Softtouch Ii Lancet Device

Class II

See all devices from Boehringer Mannheim Corp. →