Product code JKD— Clinical Chemistry

FDA has cleared 10 devices under product code JKD between 1981 and 1996, filed by 9 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

• 19961 clearance
• 19951 clearance
• 19901 clearance
• 19851 clearance
• 19842 clearances
• 19821 clearance
• 19813 clearances

• Diagnostic Products Corp.2 clearances
• Tosoh Medics, Inc.1 clearance
• Serono Diagnostics, Inc.1 clearance
• Mallinckrodt Critical Care1 clearance
• Institut National Des Radioelements1 clearance
• Immuno Nuclear Corp.1 clearance
• Immunex Radiochemical Diagnostics1 clearance
• Diagnostic Systems Laboratories, Inc.1 clearance
• Calbiochem-Behring Corp.1 clearance

• K951848 — AIA-PACK CPR ASSAYTosoh Medics, Inc.·1996-02-13
• K943767 — IMMULITE C-PEPTIDEDiagnostic Products Corp.·1995-03-23
• K896420 — DSL C-PEPTIDE RIA (DSL #7000)Diagnostic Systems Laboratories, Inc.·1990-05-24
• K854066 — DOUBLE ANTIBODY C-PEPTIDE RIA KITDiagnostic Products Corp.·1985-11-12
• K842267 — C-PEP-RIA-100Institut National Des Radioelements·1984-09-06
• K833396 — C-PEPTIDE RADIOIMMUNOASSAY TEST KITSerono Diagnostics, Inc.·1984-04-13
• K820666 — HUMAN C-PEPTIDE OF INSULIN BY RADIOIMM.Immuno Nuclear Corp.·1982-07-13
• K812689 — RIA QUANT C-PEPTIDE KITMallinckrodt Critical Care·1981-10-06
• K812288 — HUMAN C-PEPTIDE REAGENTSImmunex Radiochemical Diagnostics·1981-08-31
• K810718 — C-PEPTICE REAGENTSCalbiochem-Behring Corp.·1981-03-31