H. Influenza B Antisera for Cie

by Diagnostica, Inc. United States 510(k)

510(k) K823348 Product code GRP

Regulatory status

as of 26 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK823348	Date28 Dec 1982Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 9 Oct 2026)

Specification

510(k) · synced 9 Oct 2026

510(k) Number: K823348
FDA Product Code: GRP

Device Class: Class II
Regulation: 21 CFR Part 866.3300
Advisory Committee: Microbiology
FDA Decision: SESE Substantially Equivalent

Other devices from Diagnostica, Inc.

Ease-A-Cult

Class II
Buffer, Collagen Reagent and Diluent (JBX)

Class II
Anti-Human IgG Serum

Class II
Anti-Human Kappa Serum

Class II
Diagnostic Kits & Kit Components

Class I
Aspergillus Fumigatus, Aspergillus Flavu

Class I

See all devices from Diagnostica, Inc. →

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

FDA 510(k) K823348 24 fields · synced 9 Oct 2026