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

Reagent, Rickettsia Serological

21 CFR 866.3500 / Microbiology
FDA source (opens on fda.gov)

LSQ is the FDA product code for Reagent, Rickettsia Serological, a class I device type, regulated under 21 CFR 866.3500. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
LSQ
Device name
Reagent, Rickettsia Serological
Regulation
21 CFR 866.3500
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
4
Ingested recalls
0

Clearances, product code LSQ

By decision year
4 clearances under product code LSQ with a decision year between 1987 and 1998, 1987 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code LSQ by decision year
YearClearances
19871
19901
19931
19981

Applicants with the most clearances

Product code LSQ
Applicants holding the most 510(k) clearances under product code LSQ
ApplicantClearances
Intercare Diagnostics, Inc.2
David C. Bishop, Ph.D.1
Health Research, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code