COMBI SCAN 500 URINE TEST STRIP ANALYZER, MODEL A93005— 510(k) K061812

Name: FDA 510(k) clearance K061812
Creator: U.S. Food and Drug Administration
Published: 2007-04-06

Substantially Equivalent

Analyticon Biotechnologies AG

FDA 510(k) clearance K061812 for COMBI SCAN 500 URINE TEST STRIP ANALYZER, MODEL A93005, Substantially Equivalent on 2007-04-06. Applicant: Analyticon Biotechnologies AG. Device class: 2.

Clearance details

Applicant: Analyticon Biotechnologies AG
Product code: Code JIL
Device class: Class 2
Regulation: 21 CFR 862.1340
Advisory panel: Clinical Chemistry
Date received: 2006-06-26
Decision date: 2007-04-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lichtenfels, Hessen, DE

Download summary PDF View on FDA.gov ↗

Recent devices under product code JIL

view all

K193514 — AUTION MAX AX-4060 Urinalysis System2023-04-13
K183432 — cobas u 601 urinalysis test system2019-05-07
K173327 — DIP/U.S. Urine Analysis Test System2018-07-18
K180356 — inui In-Home Urine Analysis Test System2018-05-25
K181024 — DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips2018-05-23

More clearances from Analyticon Biotechnologies AG

view all

K061846 — COMBI SCAN1002007-04-06
K023885 — COMBI-SCREEN, MODELS 10SL AND 11SL2003-10-21

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