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

Protamine Sulphate

21 CFR 864.7525 / Hematology
FDA source (opens on fda.gov)

GFT is the FDA product code for Protamine Sulphate, a class II device type, regulated under 21 CFR 864.7525. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GFT
Device name
Protamine Sulphate
Regulation
21 CFR 864.7525
Device class
Class II
Review panel
Hematology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
2
Ingested recalls
0

Clearances, product code GFT

By decision year
2 clearances under product code GFT with a decision year between 1991 and 1995, 1991 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code GFT by decision year
YearClearances
19911
19951

Applicants with the most clearances

Product code GFT
Applicants holding the most 510(k) clearances under product code GFT
ApplicantClearances
Accriva Diagnostics, Inc.1
Medtronic Hemotec, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code