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

Test Reagents, Neisseria Gonorrhoeae Biochemical

21 CFR 866.2660 / Microbiology
FDA source (opens on fda.gov)

LTS is the FDA product code for Test Reagents, Neisseria Gonorrhoeae Biochemical, a class I device type, regulated under 21 CFR 866.2660. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
LTS
Device name
Test Reagents, Neisseria Gonorrhoeae Biochemical
Regulation
21 CFR 866.2660
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
1
Ingested recalls
0

Clearances, product code LTS

By decision year
1 clearance under product code LTS with a decision year between 1996 and 1996, 1996 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code LTS by decision year
YearClearances
19961

Applicants with the most clearances

Product code LTS
Applicants holding the most 510(k) clearances under product code LTS
ApplicantClearances
Difco Laboratories, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

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