KSI · Class II · 21 CFR 864.9550

FDA Product Code KSI: Lectins And Protectins

Leading manufacturers include American Dade.

4

Total

4

Cleared

54d

Avg days

1980

Since

FDA 510(k) Cleared Lectins And Protectins Devices (Product Code KSI)

4 devices

1–4 of 4

Cleared Apr 14, 1982

Hematology · 64d

Cleared Mar 04, 1982

Pathology · 87d

About Product Code KSI - Regulatory Context

Related FDA 510(k) Regulatory Insights

Data Source

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

Latest clearance: Apr 14, 1982

Product Code Info

Code	KSI
Device class	Class II
CFR	21 CFR 864.9550
Panel	Hematology

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View KSI classification on FDA.gov →