IDAClass I

Alcian Blue

21 CFR 864.1850 / Hematology

IDA is the FDA product code for Alcian Blue, a class I device type, regulated under 21 CFR 864.1850. As of 2026-09-10, FDA records hold 2 510(k) clearances under this code, the most recent dated 1983-09-12, and no recalls.

Classification record

Product code: IDA
Device name: Alcian Blue
Regulation: 21 CFR 864.1850
Device class: Class I
Review panel: Hematology
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: Yes
Third party review eligible: No
Ingested clearances: 2
Ingested recalls: 0

Clearances, product code IDA

By decision year

2 clearances under product code IDA with a decision year between 1980 and 1983, 1980 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code IDA by decision year
Year	Clearances
1980	1
1983	1

Applicants with the most clearances

Product code IDA

Applicants holding the most 510(k) clearances under product code IDA
Applicant	Clearances
Helena Laboratories, Corp.	1
Volu Sol Medical Industries	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 15 companies shown, in name order

Recent clearances

Product code IDA

Recent recalls

Product code IDA

FDA records show no recalls under product code IDA.

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)