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

Test, Leukocyte Typing

21 CFR 864.7675 / Hematology
FDA source (opens on fda.gov)

LGO is the FDA product code for Test, Leukocyte Typing, a class I device type, regulated under 21 CFR 864.7675. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
LGO
Device name
Test, Leukocyte Typing
Regulation
21 CFR 864.7675
Device class
Class I
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
5
Ingested recalls
0

Clearances, product code LGO

By decision year
5 clearances under product code LGO with a decision year between 1977 and 1990, 1977 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code LGO by decision year
YearClearances
19772
19791
19881
19901

Applicants with the most clearances

Product code LGO
Applicants holding the most 510(k) clearances under product code LGO
ApplicantClearances
Hyland Therapeutic Div., Travenol Laboratories2
Calbiochem-Behring Corp.1
Kallestad Diag, A Div. of Erbamont, Inc.1
Molecular Biosystems, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code