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

Igg (Gamma Chain Specific), Antigen, Antiserum, Control

21 CFR 866.5510 / Immunology
FDA source (opens on fda.gov)

DFZ is the FDA product code for Igg (Gamma Chain Specific), Antigen, Antiserum, Control, a class II device type, regulated under 21 CFR 866.5510. As of , FDA records hold 9 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
DFZ
Device name
Igg (Gamma Chain Specific), Antigen, Antiserum, Control
Regulation
21 CFR 866.5510
Device class
Class II
Review panel
Immunology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
9
Ingested recalls
0

Clearances, product code DFZ

By decision year
9 clearances under product code DFZ with a decision year between 1979 and 2009, 1979 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code DFZ by decision year
YearClearances
19792
19812
19941
19961
20022
20091

Applicants with the most clearances

Product code DFZ
Applicants holding the most 510(k) clearances under product code DFZ
ApplicantClearances
Kent Laboratories, Inc.2
The Binding Site2
Boehringer Mannheim Corp.1
Icl Scientific1
Immulok, Inc.1
Sanquin Blood Supply Foundation1
Siemens Healthcare Diagnostics Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code