510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
LSRClass II

Reagent, Borrelia Serological Reagent

21 CFR 866.3830 / Microbiology
FDA source (opens on fda.gov)

LSR is the FDA product code for Reagent, Borrelia Serological Reagent, a class II device type, regulated under 21 CFR 866.3830. As of , FDA records hold 112 510(k) clearances under this code, the most recent dated , and 5 recalls.

Classification record

Product code
LSR
Device name
Reagent, Borrelia Serological Reagent
Regulation
21 CFR 866.3830
Device class
Class II
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
112
Ingested recalls
5

Clearances, product code LSR

By decision year
112 clearances under product code LSR with a decision year between 1987 and 2026, 1989 the highest year at 15.
Show the numbers
510(k) clearances under FDA product code LSR by decision year
YearClearances
19872
19883
198915
19904
199112
19922
19951
19964
19972
199810
19999
20001
20011
20033
20052
20071
20082
20092
20101
20123
20132
20151
20161
20176
20183
20194
20203
20216
20221
20231
20241
20252
20261

Applicants with the most clearances

Product code LSR
Applicants holding the most 510(k) clearances under product code LSR
ApplicantClearances
Zeus Scientific LLC13
Gold Standard Diagnostics, LLC9
Viramed Biotech AG7
Mardx Diagnostics, Inc.6
Boston Biomedica, Inc.4
Diasorin Inc.4
Diamedix Corp.4
General Biometrics, Inc.4
Hillcrest Biologicals4
Medical Diagnostic Technologies, Inc.4

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 25 companies shown, in name order