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

Solution, Formalin-Sodium Acetate

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

IGB is the FDA product code for Solution, Formalin-Sodium Acetate, a class I device type, regulated under 21 CFR 864.4010. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
IGB
Device name
Solution, Formalin-Sodium Acetate
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
1
Ingested recalls
0

Clearances, product code IGB

By decision year
1 clearance under product code IGB with a decision year between 1980 and 1980, 1980 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code IGB by decision year
YearClearances
19801

Applicants with the most clearances

Product code IGB
Applicants holding the most 510(k) clearances under product code IGB
ApplicantClearances
Remel Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code