LKHClass I

Antisera, Immunoperoxidase, Chlamydia Spp.

21 CFR 866.3120 / Microbiology

LKH is the FDA product code for Antisera, Immunoperoxidase, Chlamydia Spp., a class I device type, regulated under 21 CFR 866.3120. As of 2026-09-10, FDA records hold 8 510(k) clearances under this code, the most recent dated 1991-03-19, and 6 recalls.

Classification record

Product code: LKH
Device name: Antisera, Immunoperoxidase, 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: 8
Ingested recalls: 6

Clearances, product code LKH

By decision year

8 clearances under product code LKH with a decision year between 1982 and 1991, 1989 the highest year at 2.

Show the numbers

510(k) clearances under FDA product code LKH by decision year
Year	Clearances
1982	1
1983	1
1984	1
1985	1
1989	2
1991	2

Applicants with the most clearances

Product code LKH

Applicants holding the most 510(k) clearances under product code LKH
Applicant	Clearances
Savyon Diagnostics Ltd.	2
Bartels Immunodiagnostic Supplies, Inc.	1
Difco Laboratories, Inc.	1
Icn Immunobiologicals	1
Immulok, Inc.	1
Nicholas H. Maganias	1
Scott Laboratories, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code LKH.