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

Total Spinal-Fluid, Antigen, Antiserum, Control

21 CFR 866.5860 / Immunology
FDA source (opens on fda.gov)

DFI is the FDA product code for Total Spinal-Fluid, Antigen, Antiserum, Control, a class I device type, regulated under 21 CFR 866.5860. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
DFI
Device name
Total Spinal-Fluid, Antigen, Antiserum, Control
Regulation
21 CFR 866.5860
Device class
Class I
Review panel
Immunology
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 DFI

By decision year
4 clearances under product code DFI with a decision year between 1983 and 1985, 1984 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code DFI by decision year
YearClearances
19831
19842
19851

Applicants with the most clearances

Product code DFI
Applicants holding the most 510(k) clearances under product code DFI
ApplicantClearances
Canyon Diagnostics, Inc.1
Intl. Diagnostic Technology1
Isolab, Inc.1
Somas Medical Industries, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code