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

Ldl & Vldl Precipitation, Hdl

21 CFR 862.1475 / Clinical Chemistry
FDA source (opens on fda.gov)

LBR is the FDA product code for Ldl & Vldl Precipitation, Hdl, a class I device type, regulated under 21 CFR 862.1475. As of , FDA records hold 66 510(k) clearances under this code, the most recent dated , and 11 recalls.

Classification record

Product code
LBR
Device name
Ldl & Vldl Precipitation, Hdl
Regulation
21 CFR 862.1475
Device class
Class I
Review panel
Clinical Chemistry
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
66
Ingested recalls
11

Clearances, product code LBR

By decision year
66 clearances under product code LBR with a decision year between 1978 and 2015, 1988 the highest year at 6.
Show the numbers
510(k) clearances under FDA product code LBR by decision year
YearClearances
19782
19794
19801
19812
19821
19831
19844
19851
19861
19886
19896
19906
19914
19922
19935
19941
19952
19961
19973
19983
19995
20011
20021
20051
20081
20151

Applicants with the most clearances

Product code LBR
Applicants holding the most 510(k) clearances under product code LBR
ApplicantClearances
Genzyme Corporation3
Merchant House Scientific3
Horiba Instruments Incorporated3
American Monitor Corp.2
Boehringer Mannheim Corp.2
Sekisui Diagnostics P.E.I. Inc.2
Ortho-Clinical Diagnostics, Inc.2
Preventive Diagnostics Corp.2
Reference Diagnostics, Inc.2
Roche Diagnostic Systems, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 35 companies shown, in name order