510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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IGEClass I

Solution, Formalin Ammonium Bromide

21 CFR 864.4010 / Pathology
FDA source (opens on fda.gov)

IGE is the FDA product code for Solution, Formalin Ammonium Bromide, a class I device type, regulated under 21 CFR 864.4010. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
IGE
Device name
Solution, Formalin Ammonium Bromide
Regulation
21 CFR 864.4010
Device class
Class I
Review panel
Pathology
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 IGE

By decision year
2 clearances under product code IGE with a decision year between 1984 and 1995, 1984 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code IGE by decision year
YearClearances
19841
19951

Applicants with the most clearances

Product code IGE
Applicants holding the most 510(k) clearances under product code IGE
ApplicantClearances
Anatech, Ltd.1
Busse Hospital Disposables1

Companies listing this code with FDA

Companies whose registered establishments list this code

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