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

Assay, Heparin

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

KFF is the FDA product code for Assay, Heparin, a class II device type, regulated under 21 CFR 864.7525. As of , FDA records hold 46 510(k) clearances under this code, the most recent dated , and 12 recalls.

Classification record

Product code
KFF
Device name
Assay, Heparin
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
47
Ingested recalls
12

Clearances, product code KFF

By decision year
47 clearances under product code KFF with a decision year between 1979 and 2026, 1995 the highest year at 9.
Show the numbers
510(k) clearances under FDA product code KFF by decision year
YearClearances
19791
19811
19831
19844
19852
19861
19871
19891
19904
19912
19931
19943
19959
19961
19972
19982
20012
20023
20061
20091
20111
20171
20221
20261

Applicants with the most clearances

Product code KFF
Applicants holding the most 510(k) clearances under product code KFF
ApplicantClearances
American Bioproducts Co.8
Instrumentation Laboratory Co.6
Sekisui Diagnostics, LLC2
Cardiovascular Diagnostics, Inc.2
Diagnostica Stago, Inc.2
E.I. Dupont de Nemours & Co., Inc.2
Accriva Diagnostics, Inc.2
bioMerieux, Inc.2
American Dade1
Behring Diagnostics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code