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

Lectins And Protectins

21 CFR 864.9550 / Hematology
FDA source (opens on fda.gov)

KSI is the FDA product code for Lectins And Protectins, a class II device type, regulated under 21 CFR 864.9550. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
KSI
Device name
Lectins And Protectins
Regulation
21 CFR 864.9550
Device class
Class II
Review panel
Hematology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
4
Ingested recalls
0

Clearances, product code KSI

By decision year
4 clearances under product code KSI with a decision year between 1980 and 1982, 1980 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code KSI by decision year
YearClearances
19802
19822

Applicants with the most clearances

Product code KSI
Applicants holding the most 510(k) clearances under product code KSI
ApplicantClearances
American Dade2
Gamma Biologicals, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code