ANTI-HUMAN LAMBDA SERUM— 510(k) K791283

Substantially Equivalent

Diagnostica, Inc.

FDA 510(k) clearance K791283 for ANTI-HUMAN LAMBDA SERUM, Substantially Equivalent on 1979-11-27. Applicant: Diagnostica, Inc.. Device class: 2.

Clearance details

Applicant: Diagnostica, Inc.
Product code: Code DEH
Device class: Class 2
Regulation: 21 CFR 866.5550
Advisory panel: Immunology
Date received: 1979-07-10
Decision date: 1979-11-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DEH

K172471 — VENTANA CD30 (Ber-H2) RxDx Assay2018-05-08
K140396 — FREELITE HUMAN LAMBDA FREE KIT2014-04-16
K083601 — LAMBDA LIGHT CHAINS2009-06-22
K033811 — FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE OLYMPUS AU ANALYZER2004-01-30
K031016 — FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE DAD BEHRING NEPHELOMETER II2003-07-15

More clearances from Diagnostica, Inc.

K002756 — EASE-A-CULT2001-02-23
K823348 — H. INFLUENZA B ANTISERA FOR CIE1982-12-28
K812434 — DIAGNOSTIC KITS & KIT COMPONENTS1981-09-23
K800398 — PARACONTROL ABNORMAL IMMUNOGLOBULIN CONT1980-03-12
K791281 — ANTI-HUMAN IGG SERUM1979-11-27

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