DIIClass I

Columns, Glc

21 CFR 862.2250 / Clinical Chemistry

DII is the FDA product code for Columns, Glc, a class I device type, regulated under 21 CFR 862.2250. As of 2026-09-10, FDA records hold 5 510(k) clearances under this code, the most recent dated 1988-01-21, and no recalls.

Classification record

Product code: DII
Device name: Columns, Glc
Regulation: 21 CFR 862.2250
Device class: Class I
Review panel: Clinical Chemistry
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 5
Ingested recalls: 0

Clearances, product code DII

By decision year

5 clearances under product code DII with a decision year between 1979 and 1988, 1984 the highest year at 2.

Show the numbers

510(k) clearances under FDA product code DII by decision year
Year	Clearances
1979	1
1984	2
1986	1
1988	1

Applicants with the most clearances

Product code DII

Applicants holding the most 510(k) clearances under product code DII
Applicant	Clearances
Supelco, Inc.	3
Hewlett-Packard Co.	1
Lkb Instruments, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code DII.

Recent clearances

Product code DII

Recent recalls

Product code DII

FDA records show no recalls under product code DII.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)