FLOR. CONJUG. HUMAN FAB FRAGMENT— 510(k) K770670

Name: FDA 510(k) clearance K770670
Creator: U.S. Food and Drug Administration
Published: 1977-04-28

Substantially Equivalent

Kent Laboratories, Inc.

FDA 510(k) clearance K770670 for FLOR. CONJUG. HUMAN FAB FRAGMENT, Substantially Equivalent on 1977-04-28. Applicant: Kent Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Kent Laboratories, Inc.
Product code: Code DFK
Device class: Class 1
Regulation: 21 CFR 866.5520
Advisory panel: Immunology
Date received: 1977-04-08
Decision date: 1977-04-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DFK

view all

K790711 — ANTISERA TO HUMAN FRAGMENT1979-09-04
K771243 — ANTISERA TO HUMAN FAB FRAGMENT1977-08-03

More clearances from Kent Laboratories, Inc.

view all

K951966 — HUMAN PREALBUMIN RADIAL IMMUNODIFFUSION KIT1995-06-01
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

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