DIASLIDE URINE CULTURING DEVICE— 510(k) K921045

Name: FDA 510(k) clearance K921045
Creator: U.S. Food and Drug Administration
Published: 1992-09-28

Substantially Equivalent

Savyon Diagnostics , Ltd.

FDA 510(k) clearance K921045 for DIASLIDE URINE CULTURING DEVICE, Substantially Equivalent on 1992-09-28. Applicant: Savyon Diagnostics , Ltd.. Device class: 1.

Clearance details

Applicant: Savyon Diagnostics , Ltd.
Product code: Code JXA
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 1992-03-04
Decision date: 1992-09-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ashdod, IL

Download summary PDF View on FDA.gov ↗

Recent devices under product code JXA

view all

K011043 — OSMETECH MICROBIAL ANALYSER-URINARY TRACT INFECTION DETECTOR (OMA-UTI)2001-11-30
K981084 — URISCREEN1998-10-07
K972676 — URINE SCREENING DEVICE1998-02-23
K952246 — TRI-TECHIN. CUSTOM BLOOD AND/OR URINE TRANSPORT KIT1995-06-20
K950257 — MULTIPLE (IZON DBS & URINE COLLECTION KIT)1995-04-14

More clearances from Savyon Diagnostics , Ltd.

view all

K914327 — SEROELISA(TM) CHLAMYDIA IGA TEST KIT1992-06-09
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.