JKD — Radioimmunoassay, C-Peptides Of Proinsulin Class I

FDA Device Classification

Classification Details

Product Code
JKD
Device Class
Class I
Regulation Number
862.1135
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K951848tosoh medicsAIA-PACK CPR ASSAYFebruary 13, 1996
K943767diagnostic productsIMMULITE C-PEPTIDEMarch 23, 1995
K896420diagnostic systems laboratoriesDSL C-PEPTIDE RIA (DSL #7000)May 24, 1990
K854066diagnostic productsDOUBLE ANTIBODY C-PEPTIDE RIA KITNovember 12, 1985
K842267institut national des radioelementsC-PEP-RIA-100September 6, 1984
K833396serono diagnosticsC-PEPTIDE RADIOIMMUNOASSAY TEST KITApril 13, 1984
K820666immuno nuclearHUMAN C-PEPTIDE OF INSULIN BY RADIOIMM.July 13, 1982
K812689mallinckrodt critical careRIA QUANT C-PEPTIDE KITOctober 6, 1981
K812288immunex radiochemical diagnosticsHUMAN C-PEPTIDE REAGENTSAugust 31, 1981
K810718calbiochem-behringC-PEPTICE REAGENTSMarch 31, 1981