GOAT LAMBDA-LIGHT CHAIN ANTI-HUMAN SERUM— 510(k) K771768

Name: FDA 510(k) clearance K771768
Creator: U.S. Food and Drug Administration
Published: 1977-10-07

Substantially Equivalent

G.D. Searle and Co.

FDA 510(k) clearance K771768 for GOAT LAMBDA-LIGHT CHAIN ANTI-HUMAN SERUM, Substantially Equivalent on 1977-10-07. Applicant: G.D. Searle and Co.. Device class: 2.

Clearance details

Applicant: G.D. Searle and Co.
Product code: Code DEH
Device class: Class 2
Regulation: 21 CFR 866.5550
Advisory panel: Immunology
Date received: 1977-09-19
Decision date: 1977-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DEH

view all

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 G.D. Searle and Co.

view all

K821159 — IN-LINE OXYGEN MONITORING SYSTEM1982-05-25
K811068 — BYPASS COIL1981-05-27
K811071 — VENOUS OXYGEN PROBE1981-05-05
K803238 — INTRAVASCULAR CATHETER1981-04-23
K810630 — SILICONE ELASTOMER COATED LATEX FOLEY1981-03-31

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