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

Urinary Homocystine (Nonquantitative) Test System

21 CFR 862.1377 / Clinical Chemistry
FDA source (opens on fda.gov)

LPS is the FDA product code for Urinary Homocystine (Nonquantitative) Test System, a class II device type, regulated under 21 CFR 862.1377. As of , FDA records hold 29 510(k) clearances under this code, the most recent dated , and 18 recalls.

Classification record

Product code
LPS
Device name
Urinary Homocystine (Nonquantitative) Test System
Regulation
21 CFR 862.1377
Device class
Class II
Review panel
Clinical Chemistry
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
29
Ingested recalls
18

Clearances, product code LPS

By decision year
29 clearances under product code LPS with a decision year between 1998 and 2013, 2006 the highest year at 6.
Show the numbers
510(k) clearances under FDA product code LPS by decision year
YearClearances
19981
19994
20015
20032
20041
20066
20072
20082
20091
20124
20131

Applicants with the most clearances

Product code LPS
Applicants holding the most 510(k) clearances under product code LPS
ApplicantClearances
Diazyme Laboratories, Inc.4
Axis-Shield Diagnostics, Ltd.3
Siemens Healthcare Diagnostics Inc.3
Anticancer, Inc.2
Axis Biochemicals, ASA2
Bayer Diagnostics Corp.2
Ortho-Clinical Diagnostics, Inc.2
Abbott Medical1
Bio-Rad1
Catch Incorporated1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 20 companies shown, in name order