CHLAMYDIA (LGV-1)— 510(k) K894625

Substantially Equivalent

Bion Ent., Ltd.

FDA 510(k) clearance K894625 for CHLAMYDIA (LGV-1), Substantially Equivalent on 1989-08-15. Applicant: Bion Ent., Ltd.. Device class: 1.

Clearance details

Applicant: Bion Ent., Ltd.
Product code: Code LKI
Device class: Class 1
Regulation: 21 CFR 866.3120
Advisory panel: Microbiology
Date received: 1989-07-20
Decision date: 1989-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Park Ridge, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LKI

K914953 — IFA FOR CHLAMYDIA TRACHOMATIS IGG ANTIBODY1992-02-19
K905531 — LUPUS(LE)-LATEX TEST1991-01-25
K883776 — BTC CHLAMYDIA DIRECT SPECIMEN TEST & CONTROL SLIDE1989-02-03
K854615 — MONABRITE CHLAMYDIA TRACH CULTURE CONFIRMATION TES1986-01-28
K830342 — CULUTURE SET CHLAMYDIA ISOLATION AND1983-05-04

More clearances from Bion Ent., Ltd.

K926066 — BION MUMPS-G ANTIBODY TEST SYSTEM1993-06-15
K901054 — BION BORRELIA BURGDORFERI ANTIGEN SUBSTRATE SLIDE1990-04-05
K894622 — VARICELLA ZOSTER VIRUS1989-10-24
K894623 — RESPIRATORY SYNCYTIAL VIRUS1989-10-16
K894624 — MUMPS VIRUS1989-10-16

Data sourced from openFDA. This site is unofficial and independent of the FDA.