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

Respiratory Syncytial Virus, Antigen, Antibody, Ifa

21 CFR 866.3480 / Microbiology
FDA source (opens on fda.gov)

LKT is the FDA product code for Respiratory Syncytial Virus, Antigen, Antibody, Ifa, a class I device type, regulated under 21 CFR 866.3480. As of , FDA records hold 23 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
LKT
Device name
Respiratory Syncytial Virus, Antigen, Antibody, Ifa
Regulation
21 CFR 866.3480
Device class
Class I
Review panel
Microbiology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
23
Ingested recalls
0

Clearances, product code LKT

By decision year
23 clearances under product code LKT with a decision year between 1983 and 2008, 1987 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code LKT by decision year
YearClearances
19831
19842
19853
19862
19875
19882
19891
19913
19942
19991
20081

Applicants with the most clearances

Product code LKT
Applicants holding the most 510(k) clearances under product code LKT
ApplicantClearances
Baxter Diagnostics, Inc.2
Siemens Healthcare Diagnostics Inc.2
Genetic Systems Corp.2
Gull Laboratories, Inc.2
Ortho Diagnostic Systems, Inc.2
Abbott Medical1
Bartels Immunodiagnostic Supplies, Inc.1
Bion Ent., Ltd.1
Ortho-Clinical Diagnostics, Inc.1
Difco Laboratories, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code