FEMEXAM TESTCARD— 510(k) K962718

Substantially Equivalent

Litmus Concepts, Inc.

FDA 510(k) clearance K962718 for FEMEXAM TESTCARD, Substantially Equivalent on 1997-02-07. Applicant: Litmus Concepts, Inc.. Device class: 1.

Clearance details

Applicant: Litmus Concepts, Inc.
Product code: Code CEN
Device class: Class 1
Regulation: 21 CFR 862.1550
Advisory panel: Clinical Chemistry
Date received: 1996-07-12
Decision date: 1997-02-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Front Royal, VA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CEN

K091287 — VS-SENSE TEST2009-08-31
K071100 — AMNISCREEN HOME DETECTION LINER KIT2007-10-15
K051727 — AIMSTICK URINE REAGENT STRIPS2005-10-26
K040008 — QUICKVUE ADVANCE PH AND AMINES GLL TEST2004-04-29
K030650 — STONEGUARD II REAGENT STRIPS FOR URINALYSIS AND CONFIRM CONTROL SOLUTIONS2003-04-14

More clearances from Litmus Concepts, Inc.

K964015 — INDICARD TEST1997-06-19

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