SEROELISA(TM) CHLAMYDIA IGA TEST KIT— 510(k) K914327

Name: FDA 510(k) clearance K914327
Creator: U.S. Food and Drug Administration
Published: 1992-06-09

Substantially Equivalent

Savyon Diagnostics , Ltd.

FDA 510(k) clearance K914327 for SEROELISA(TM) CHLAMYDIA IGA TEST KIT, Substantially Equivalent on 1992-06-09. Applicant: Savyon Diagnostics , Ltd.. Device class: 1.

Clearance details

Applicant: Savyon Diagnostics , Ltd.
Product code: Code LJC
Device class: Class 1
Regulation: 21 CFR 866.3120
Advisory panel: Microbiology
Date received: 1991-09-27
Decision date: 1992-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ashdod, IL

Download summary PDF View on FDA.gov ↗

Recent devices under product code LJC

view all

K032330 — CT OIA2004-03-02
K033865 — IDEIA PCE CHLAMYDIA2004-01-21
K033079 — CHLAMYDIA IGG ELISA TEST SYSTEM2003-11-26
K982210 — MODIFICATION OF SYVA MICROTRAK II CHLAMYDIA EIA1998-07-09
K962558 — CHLAMYDIA IGG ELISA TEST SYSTEM1997-02-24

More clearances from Savyon Diagnostics , Ltd.

view all

K921045 — DIASLIDE URINE CULTURING DEVICE1992-09-28
K915281 — SEROLISA CHLAMYDIA IGG TEST KIT1992-03-23
K910644 — IPAZYME (TM) CHLAMYDIA IGG-IGA1991-03-19
K901975 — IPAZYME(TM) CHLAMYDIA TRUE IGM(TM)1991-03-08

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