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

Enzyme Linked Immunoabsorption Assay, Treponema Pallidum

21 CFR 866.3830 / Microbiology
FDA source (opens on fda.gov)

LIP is the FDA product code for Enzyme Linked Immunoabsorption Assay, Treponema Pallidum, a class II device type, regulated under 21 CFR 866.3830. As of , FDA records hold 35 510(k) clearances under this code, the most recent dated , and 18 recalls.

Classification record

Product code
LIP
Device name
Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Regulation
21 CFR 866.3830
Device class
Class II
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
35
Ingested recalls
18

Clearances, product code LIP

By decision year
35 clearances under product code LIP with a decision year between 1982 and 2024, 1988 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code LIP by decision year
YearClearances
19821
19851
19871
19883
19903
19912
19951
19962
19991
20002
20021
20063
20071
20091
20101
20112
20122
20163
20171
20211
20242

Applicants with the most clearances

Product code LIP
Applicants holding the most 510(k) clearances under product code LIP
ApplicantClearances
Mercia Diagnostics, Ltd.4
Siemens Healthcare Diagnostics Inc.3
Bio-Rad Laboratories Inc.3
Diasorin Inc.2
Diagnostic Chemicals, Ltd. (USA)2
Ortho Diagnostic Systems, Inc.2
Phoenix Biotech Corp.2
Pyramid Biological Corp.2
Roche Diagnostics GmbH2
Trinity Biotech, PLC2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 23 companies shown, in name order