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

Fibrometer

21 CFR 864.5400 / Hematology
FDA source (opens on fda.gov)

GIE is the FDA product code for Fibrometer, a class II device type, regulated under 21 CFR 864.5400. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GIE
Device name
Fibrometer
Regulation
21 CFR 864.5400
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
2
Ingested recalls
0

Clearances, product code GIE

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

Applicants with the most clearances

Product code GIE
Applicants holding the most 510(k) clearances under product code GIE
ApplicantClearances
American Scientific Products2

Companies listing this code with FDA

Companies whose registered establishments list this code