Atlas FDA

72 DETERM. SIZE RADIAL IMMUNO. TEST HUMAN CERULOPL

FDA 510(k) clearance K850682 · decided 1985-11-25

Clearance details

K-number
K850682
Device name
72 DETERM. SIZE RADIAL IMMUNO. TEST HUMAN CERULOPL
Applicant
Kent Laboratories, Inc.
Decision
Substantially Equivalent
Date received
1985-02-21
Decision date
1985-11-25
Days to decision
277 days
Clearance type
Traditional
Product code
DDB
Device class
2
Regulation number
866.5210
Medical specialty
Immunology
Advisory committee
Immunology
Location
Redmond, WA, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

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
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

Recalls involving this device

No recalls on record reference this clearance.