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

Antismooth Muscle Antibody, Indirect Immunofluorescent, Antigen, Control

21 CFR 866.5120 / Immunology
FDA source (opens on fda.gov)

DBE is the FDA product code for Antismooth Muscle Antibody, Indirect Immunofluorescent, Antigen, Control, a class II device type, regulated under 21 CFR 866.5120. As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
DBE
Device name
Antismooth Muscle Antibody, Indirect Immunofluorescent, Antigen, Control
Regulation
21 CFR 866.5120
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
6
Ingested recalls
0

Clearances, product code DBE

By decision year
6 clearances under product code DBE with a decision year between 1976 and 1981, 1980 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code DBE by decision year
YearClearances
19761
19771
19791
19802
19811

Applicants with the most clearances

Product code DBE
Applicants holding the most 510(k) clearances under product code DBE
ApplicantClearances
Calbiochem-Behring Corp.1
Clinical Sciences, Inc.1
Immuno-Products Industries1
Medica Corp.1
Meloy Laboratories, Inc.1
Zeus Scientific LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code