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ALPHA1ANTITRYPSIN for Technicon Dpa-1(Tm) System

by Technicon Instruments Corp. 510(k)

Active United States

510(k) K882446

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK882446 Date8 Jul 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  • Withdrawn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
DEM
Device Class
Class II
Regulation
21 CFR Part 866.5130
Advisory Committee
Immunology
FDA Decision
SESE Substantially Equivalent

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