Atlas FDA

DDB

19 FDA 510(k) clearances · Product code

57 daysmedian time to decision
252 days90th percentile
19clearances measured

FDA profile

Official device name
Ceruloplasmin, Antigen, Antiserum, Control
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5210
Medical specialty
Immunology
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RecordFirmDate
Ceruloplasmin (K161508)Beckman Coulter Ireland, Inc.2017-01-09
HUMAN CAERULOPLASMIN KIT (K122965)The Binding Site Group , Ltd.2013-06-03
N ANTISERA TO HUMAN CERULOPLASMIN (K053074)Dade Behring, Inc.2006-03-16
IMMAGE IMMUNOCHEMISTRY SYSTEM CERULOPLASMIN (CER) REAGENT (K964762)Beckman Instruments, Inc.1997-04-25
CAERULOPLASMIN IMMUNOLOGICAL NL TEST KIT (K913668)The Binding Site, Ltd.1991-12-20
QM300 CERULOPLASMIN ANTIBODY PACK (K895377)Kallestad Diag, A Div. of Erbamont, Inc.1989-09-21
NO. 615 DETERMINATION OF CERULOPLASMIN IN SERUM (K860138)Sigma Diagnostics, Inc.1986-03-28
72 DETERM. SIZE RADIAL IMMUNO. TEST HUMAN CERULOPL (K850682)Kent Laboratories, Inc.1985-11-25
LASER CERULOPLASMIN KIT(CERULOPLASMIN REAGENTS) (K852247)Behring Diagnostics, Inc.1985-07-10
RADIAL IMMUNODIFFUSION PLATES-CERULOPLASMIN (K851283)Cooper Biomedical, Inc.1985-05-23
QUANTIMETRIC 2 CERULOPLASMIN ASSAY (K823107)Kallestad Laboratories, Inc.1982-11-16
IMMUNOGL. FRCT. OF RABBIT ANTISER.-CERUL (K812486)Dako Corp.1981-09-23
J.T. BAKER CERULOPLASMIN NEPHELOMETRIC (K801661)J.T. Baker Chemical Co.1980-09-16
ANTISERUM TO HUMAN, ALPHA-2-MACROGLOBULI (K790712)Kent Laboratories, Inc.1979-08-16
HUMAN CERULOPLASMIN (K791339)Beckman Instruments, Inc.1979-08-16
ANTISERUM TO HUMAN CERULOPLASMIN (K790714)Kent Laboratories, Inc.1979-08-16
CERUOPLASMIN SERUM ANTI-HUMAN (K781024)Icl Scientific1978-08-14
CERULOPLASMIN NEPHEL. ASSAY (K772255)Kallestad Laboratories, Inc.1978-01-05
LAS-R CERULOPLASMIN TEST (K771795)Hyland Therapeutic Div., Travenol Laboratories1977-11-14

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Every clearance here is in the API, with alerts when new ones post.