CARDIO REP LD CONTROL - CAT NO. 3325— 510(k) K950801

Name: FDA 510(k) clearance K950801
Creator: U.S. Food and Drug Administration
Published: 1995-03-30

Substantially Equivalent

Helena Laboratories

FDA 510(k) clearance K950801 for CARDIO REP LD CONTROL - CAT NO. 3325, Substantially Equivalent on 1995-03-30. Applicant: Helena Laboratories. Device class: 1.

Clearance details

Applicant: Helena Laboratories
Product code: Code JJT
Device class: Class 1
Regulation: 21 CFR 862.1660
Advisory panel: Clinical Chemistry
Date received: 1995-02-21
Decision date: 1995-03-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beaumont, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JJT

view all

K090940 — SPOTCHECK BLOOD SPOT CONTROL, ASSAYED2009-12-14
K062751 — MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKER2006-10-03
K030768 — CLINIQA LIQUID QC CARDIAC MARKER CONTROL LEVELS 1, 2 & 3, TRI-LEVEL2003-03-21
K030102 — ADVIA CENTAUR AND ACS:180 LIQUID CARDIAC MARKERS 1, 2, 32003-01-24
K021498 — LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVEL2002-05-24

More clearances from Helena Laboratories

view all

K131479 — V8 SP NORMAL CONTROL, ABNORMAL CONTROL2013-10-07
K100103 — SPECIALTY ASSAYED CONTROL-22010-12-15
K061991 — PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA2007-02-23
K061069 — SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALENT KIT, MODEL 34582006-07-06
K061014 — ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP2006-05-10

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