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

Antiparietal Antibody, Indirect Immunofluorescent, Antigen, Control

21 CFR 866.5110 / Immunology
FDA source (opens on fda.gov)

DBJ is the FDA product code for Antiparietal Antibody, Indirect Immunofluorescent, Antigen, Control, a class II device type, regulated under 21 CFR 866.5110. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
DBJ
Device name
Antiparietal Antibody, Indirect Immunofluorescent, Antigen, Control
Regulation
21 CFR 866.5110
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
2
Ingested recalls
0

Clearances, product code DBJ

By decision year
2 clearances under product code DBJ with a decision year between 1979 and 1993, 1979 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code DBJ by decision year
YearClearances
19791
19931

Applicants with the most clearances

Product code DBJ
Applicants holding the most 510(k) clearances under product code DBJ
ApplicantClearances
Elias U.S.A., Inc.1
Medica Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code