IGB · Class I · 21 CFR 864.4010

FDA Product Code IGB: Solution, Formalin-sodium Acetate

Leading manufacturers include Remel Co..

1

Total

1

Cleared

20d

Avg days

1980

Since

FDA 510(k) Cleared Solution, Formalin-sodium Acetate Devices (Product Code IGB)

1 devices

1–1 of 1

Cleared Dec 22, 1980

Microbiology · 20d

About Product Code IGB - Regulatory Context

Related FDA 510(k) Regulatory Insights

Data Source

FDA 510(k) public files . 175,730 total devices indexed.

Latest clearance: Dec 22, 1980

Product Code Info

Code	IGB
Device class	Class I
CFR	21 CFR 864.4010
Panel	Microbiology

Verify on FDA.gov

View IGB classification on FDA.gov →