ANTISERUM TO HUMAN PREALBUMIN— 510(k) K850686

Name: FDA 510(k) clearance K850686
Creator: U.S. Food and Drug Administration
Published: 1985-11-01

Substantially Equivalent

Kent Laboratories, Inc.

FDA 510(k) clearance K850686 for ANTISERUM TO HUMAN PREALBUMIN, Substantially Equivalent on 1985-11-01. Applicant: Kent Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Kent Laboratories, Inc.
Product code: Code JZJ
Device class: Class 1
Regulation: 21 CFR 866.5060
Advisory panel: Immunology
Date received: 1985-02-21
Decision date: 1985-11-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redmond, WA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JZJ

view all

K000661 — RANDOX PREALBUMIN2000-04-13
K972638 — TINA-QUANT PREALBUMIN1998-01-09
K951966 — HUMAN PREALBUMIN RADIAL IMMUNODIFFUSION KIT1995-06-01
K913672 — PREALBUMIN IMMUNOLOGICAL NL TEST KIT1991-12-20
K884297 — SPQ(TM) TEST SYSTEM FOR PREALBUMIN1988-11-02

More clearances from Kent Laboratories, Inc.

view all

K951967 — HUMAN C1 INACTIVATOR OR C-1 ESTERASE INHIBITOR RADIAL IMMUNODIFFUSION KIT1995-05-30
K951968 — HUMAN C1Q RADIAL IMMUNODIFFUSION KIT1995-05-30
K950102 — HUMAN C-5 RADIAL IMMUNODIFFUSION KIT1995-04-10
K850683 — 72 DETERM. SIZE RADIAL IMMUNODIFFUSION TEST ALPHA21985-11-27
K850682 — 72 DETERM. SIZE RADIAL IMMUNO. TEST HUMAN CERULOPL1985-11-25

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