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
LJPClass I

Antiserum, Fluorescent, Chlamydia Trachomatis

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

LJP is the FDA product code for Antiserum, Fluorescent, Chlamydia Trachomatis, a class I device type, regulated under 21 CFR 866.3120. As of , FDA records hold 35 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
LJP
Device name
Antiserum, Fluorescent, Chlamydia Trachomatis
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
35
Ingested recalls
0

Clearances, product code LJP

By decision year
35 clearances under product code LJP with a decision year between 1982 and 2007, 1987 the highest year at 9.
Show the numbers
510(k) clearances under FDA product code LJP by decision year
YearClearances
19821
19832
19844
19855
19866
19879
19883
19903
19941
20071

Applicants with the most clearances

Product code LJP
Applicants holding the most 510(k) clearances under product code LJP
ApplicantClearances
Syva Co.4
Syva Co.3
American Micro Scan2
Amico Lab, Inc.2
Siemens Healthcare Diagnostics Inc.2
Difco Laboratories, Inc.2
Kallestad Diag, A Div. of Erbamont, Inc.2
Orion Corp.2
Ortho Diagnostic Systems, Inc.2
Syncor Intl. Corp.2

Companies listing this code with FDA

Companies whose registered establishments list this code