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

Dna-Reagents, Campylobacter Spp.

21 CFR 866.3110 / Microbiology
FDA source (opens on fda.gov)

LQO is the FDA product code for Dna-Reagents, Campylobacter Spp., a class I device type, regulated under 21 CFR 866.3110. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
LQO
Device name
Dna-Reagents, Campylobacter Spp.
Regulation
21 CFR 866.3110
Device class
Class I
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
4
Ingested recalls
0

Clearances, product code LQO

By decision year
4 clearances under product code LQO with a decision year between 1987 and 1989, 1988 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code LQO by decision year
YearClearances
19871
19882
19891

Applicants with the most clearances

Product code LQO
Applicants holding the most 510(k) clearances under product code LQO
ApplicantClearances
Hologic, Inc.1
Integrated Genetics1
Molecular Biosystems, Inc.1
Wampole Laboratories1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code LQO.