PARAGON ELECTROPHORESIS SYS LIPOPROTEIN REAGENT TE— 510(k) K854057

Name: FDA 510(k) clearance K854057
Creator: U.S. Food and Drug Administration
Published: 1985-12-05

Substantially Equivalent

Beckman Instruments, Inc.

FDA 510(k) clearance K854057 for PARAGON ELECTROPHORESIS SYS LIPOPROTEIN REAGENT TE, Substantially Equivalent on 1985-12-05. Applicant: Beckman Instruments, Inc.. Device class: 1.

Clearance details

Applicant: Beckman Instruments, Inc.
Product code: Code JHO
Device class: Class 1
Regulation: 21 CFR 862.1475
Advisory panel: Clinical Chemistry
Date received: 1985-10-03
Decision date: 1985-12-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fullerton, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JHO

view all

K022333 — SPIFE LIPPOROTEIN-12, MODEL 33442002-08-15
K022053 — HYDRAGEL 7 LIPOPROTEIN(E), PN 4114 & HYDRAGEL LIPOPROTEIN(E) 15/30 PN 41342002-07-12
K013662 — MODIFICATION TO LIPOPRINT SYSTEM, LDL SUBFRACTIONS2002-03-08
K012789 — MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,41232002-01-17
K013466 — SPIFE 2000/3000 LIPOPROTEIN; MODEL# 3340, 3341, 3342, 33432001-12-21

More clearances from Beckman Instruments, Inc.

view all

K973448 — ACCESS TOXOPLASMA IGM REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 34460, 34465, 344691998-09-17
K982250 — ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER1998-07-14
K981403 — IMMAGE IMMUNOCHEMISTRY SYSTEM VALPROIC ACID (VPA) REAGENT1998-05-08
K981354 — ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 332111998-05-01
K980173 — ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER; 33500, 335051998-03-18

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