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

Enzyme Linked Immunoabsorbent Assay, Mumps Virus

21 CFR 866.3380 / Microbiology
FDA source (opens on fda.gov)

LJY is the FDA product code for Enzyme Linked Immunoabsorbent Assay, Mumps Virus, a class I device type, regulated under 21 CFR 866.3380. As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and 7 recalls.

Classification record

Product code
LJY
Device name
Enzyme Linked Immunoabsorbent Assay, Mumps Virus
Regulation
21 CFR 866.3380
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
8
Ingested recalls
7

Clearances, product code LJY

By decision year
8 clearances under product code LJY with a decision year between 1983 and 1999, 1983 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code LJY by decision year
YearClearances
19831
19901
19931
19941
19961
19971
19981
19991

Applicants with the most clearances

Product code LJY
Applicants holding the most 510(k) clearances under product code LJY
ApplicantClearances
Biomerieux Vitek, Inc.1
Biowhittaker Molecular Applications, Inc.1
Columbia Bioscience, Inc.1
Gull Laboratories, Inc.1
M.A. Bioproducts1
Pharmacia Eni Diagnostics, Inc.1
Quest Intl., Inc.1
Zeus Scientific LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 17 companies shown, in name order