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CFT — Radioimmunoassay, Prolactin (Lactogen) Class I

FDA Device Classification

FDA product code CFT covers "Radioimmunoassay, Prolactin (Lactogen)", a Class I medical device regulated under 21 CFR 862.1625. Submissions are reviewed by the Clinical Chemistry panel. At least 20 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
CFT
Device Class
Class I
Regulation Number
862.1625
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K971921MonobindPROLACTIN (PRL) HORMONE MICROPLATE ELISAJun 24, 1997
K970281Johnson And Johnson Clinical DiagnosticsVITROS IMMUNODIAGNOSTIC PRODUCTS PROLACTIN REAGENT PACK/CALIBRATORSFeb 25, 1997
K970188Sealite SciencesSEALITE SCIENCES, INC. AQUALITE PROLACTINFeb 20, 1997
K964748Boehringer MannheimELECSYS PROLACTIN ASSAYJan 21, 1997
K960561Diagnostic Systems LaboratoriesDSL ACTIVE PROLACTIN ELISA MODEL 10-4500Apr 26, 1996
K960060Diagnostic Systems LaboratoriesDSL ACTIVE PROLACTIN IRMAFeb 29, 1996
K954680Bio-Rad LaboratoriesACCESS PROLACTIN ASSAY (MODIFICATION)Oct 20, 1995
K953656Abbott MfgABBOTT IMX PROLACTIN(MODIFICATION)Oct 3, 1995
K953657Abbott MfgABBOTT AXSYM PROLACTIN(MODIFICATION)Sep 25, 1995
K944698Organon TeknikaAURAFLEX PROLACTIN 200 TEST PACK, CALIBRATOR PACK, DILVENT 1Mar 21, 1995
K943811Biomerieux VitekENZYME-LINKED FLUORESCENT IMMUNOASSAYNov 2, 1994
K935675Abbott LaboratoriesAXSYM PROLACTINJun 21, 1994
K941220Dupont Medical ProductsDUPONT ACA PLUS PROLACTIN (PROL) METHODJun 3, 1994
K941175Bio-Rad LaboratoriesACCESS PROLACTINJun 2, 1994
K930305Roche Diagnostic SystemsCOBAS CORE PROLACTIN EIAAug 19, 1993
K926386SyvaVISTA PROLACTIN ASSAYMar 29, 1993
K925846Diagnostic ProductsIMMULITE PROLACTINMar 5, 1993
K922715Icn BiomedicalsIMMUCHEM PRL-MW ELISAOct 5, 1992
K922170Eastman KodakAMERLITE PROLACTIN-30 ASSAYSep 2, 1992
K920921Bio ClinicELISA TUBE PROLACTIN TEST KITApr 8, 1992

FDA data resources