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

Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

21 CFR 862.2050 / Clinical Chemistry
FDA source (opens on fda.gov)

LXG is the FDA product code for Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use, a class I device type, regulated under 21 CFR 862.2050. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and 28 recalls.

Classification record

Product code
LXG
Device name
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
Regulation
21 CFR 862.2050
Device class
Class I
Review panel
Clinical Chemistry
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
Yes
Third party review eligible
No
Ingested clearances
3
Ingested recalls
28

Clearances, product code LXG

By decision year
3 clearances under product code LXG with a decision year between 1989 and 2002, 1989 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code LXG by decision year
YearClearances
19891
19951
20021

Applicants with the most clearances

Product code LXG
Applicants holding the most 510(k) clearances under product code LXG
ApplicantClearances
Zimmer GmbH1
Cambridge Diagnostic Products, Inc.1
Westmark, Sterile Packing Systems, Inc. (Sps)1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 287 companies shown, in name order