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
LJCClass I

Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)

21 CFR 866.3120 / Microbiology
FDA source (opens on fda.gov)

LJC is the FDA product code for Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group), a class I device type, regulated under 21 CFR 866.3120. As of , FDA records hold 67 510(k) clearances under this code, the most recent dated , and 7 recalls.

Classification record

Product code
LJC
Device name
Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)
Regulation
21 CFR 866.3120
Device class
Class I
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
67
Ingested recalls
7

Clearances, product code LJC

By decision year
67 clearances under product code LJC with a decision year between 1982 and 2004, 1990 the highest year at 15.
Show the numbers
510(k) clearances under FDA product code LJC by decision year
YearClearances
19821
19831
19841
19864
19874
198810
19894
199015
19916
19927
19931
19941
19953
19963
19972
19981
20031
20042

Applicants with the most clearances

Product code LJC
Applicants holding the most 510(k) clearances under product code LJC
ApplicantClearances
Abbott Medical10
Eastman Kodak Company4
Kallestad Diag, A Div. of Erbamont, Inc.4
Ortho Diagnostic Systems, Inc.4
Syva Co.4
Bio-Rad Laboratories Inc.3
Boots-Celltech Diagnostics, Inc.3
Ciba Corning Diagnostics Corp.3
Ortho-Clinical Diagnostics, Inc.3
Syva Co.3

Companies listing this code with FDA

Companies whose registered establishments list this code