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
LKIClass I

Antisera, Fluorescent, Chlamydia Spp.

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

LKI is the FDA product code for Antisera, Fluorescent, Chlamydia Spp., a class I device type, regulated under 21 CFR 866.3120. As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
LKI
Device name
Antisera, Fluorescent, Chlamydia Spp.
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
6
Ingested recalls
0

Clearances, product code LKI

By decision year
6 clearances under product code LKI with a decision year between 1983 and 1992, 1989 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code LKI by decision year
YearClearances
19831
19861
19892
19911
19921

Applicants with the most clearances

Product code LKI
Applicants holding the most 510(k) clearances under product code LKI
ApplicantClearances
Bion Ent., Ltd.1
Btc Corp.1
Immco Diagnostics, Inc.1
Immulok, Inc.1
Serono Diagnostics, Inc.1
Stellar Bio Systems, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code