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

Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control

21 CFR 866.5660 / Immunology
FDA source (opens on fda.gov)

DBL is the FDA product code for Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control, a class II device type, regulated under 21 CFR 866.5660. As of , FDA records hold 24 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
DBL
Device name
Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
Regulation
21 CFR 866.5660
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
24
Ingested recalls
1

Clearances, product code DBL

By decision year
24 clearances under product code DBL with a decision year between 1980 and 2018, 1980 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code DBL by decision year
YearClearances
19803
19811
19822
19871
19881
19892
19901
19911
19931
19941
19952
19963
19972
19982
20181

Applicants with the most clearances

Product code DBL
Applicants holding the most 510(k) clearances under product code DBL
ApplicantClearances
Immco Diagnostics, Inc.5
Light Diagnostics2
Biochemical Diagnostic, Inc.1
Calbiochem-Behring Corp.1
Cronus1
Svar Life Science AB1
IMMUNO CONCEPTS, NA, Ltd.1
Immuno-Diagnostic Products, Inc.1
Immuno-Products Industries1
Inova Diagnostics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code