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

Anti-Dna Antibody, Antigen And Control

21 CFR 866.5100 / Immunology
FDA source (opens on fda.gov)

LSW is the FDA product code for Anti-Dna Antibody, Antigen And Control, a class II device type, regulated under 21 CFR 866.5100. As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
LSW
Device name
Anti-Dna Antibody, Antigen And Control
Regulation
21 CFR 866.5100
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
8
Ingested recalls
1

Clearances, product code LSW

By decision year
8 clearances under product code LSW with a decision year between 1987 and 2018, 1987 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code LSW by decision year
YearClearances
19871
19931
20041
20061
20071
20081
20161
20181

Applicants with the most clearances

Product code LSW
Applicants holding the most 510(k) clearances under product code LSW
ApplicantClearances
Aesku Diagnostics2
Aesku.Diagnostics GmbH & Co. KG1
Biomedical Diagnostics (Bmd) SA1
Immco Diagnostics, Inc.1
Immunodiagnostics, Ltd.1
Inova Diagnostics, Inc.1
Phadia AB1

Companies listing this code with FDA

Companies whose registered establishments list this code