REP ULTRA HDL,VLDL/LDL CHOLESTEROL SYSTEM— 510(k) K904035

Name: FDA 510(k) clearance K904035
Creator: U.S. Food and Drug Administration
Published: 1990-11-09

Substantially Equivalent

Helena Laboratories

FDA 510(k) clearance K904035 for REP ULTRA HDL,VLDL/LDL CHOLESTEROL SYSTEM, Substantially Equivalent on 1990-11-09. Applicant: Helena Laboratories. Device class: 1.

Clearance details

Applicant: Helena Laboratories
Product code: Code LBT
Device class: Class 1
Regulation: 21 CFR 862.1475
Advisory panel: Clinical Chemistry
Date received: 1990-08-31
Decision date: 1990-11-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beaumont, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LBT

view all

K000568 — HDL CHOLESTEROL PLUS2000-08-04
K990250 — HYDRAGEL LDL/HDL CHOL DIRECT KIT-P.N. 4005, HYDRAGEL 7 LDL/HDL CHOL DIRECT KIT-P.N. 4103, HYDRAGEL LDL/HDL CHOL DIRECT 01999-06-18
K972015 — HYDRAGEL 7,15,30, CHOL-HDL KIT1997-10-27
K894366 — REP HDL-8 KIT, NO. 3188, REP HDL-16 KIT, NO. 31871989-08-31
K882368 — REP HDL ELECTROPHORESIS METHOD1988-08-08

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.