Product code KDT— Pathology

FDA has cleared 12 devices under product code KDT between 1977 and 1987, filed by 10 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.

• 19871 clearance
• 19861 clearance
• 19842 clearances
• 19832 clearances
• 19823 clearances
• 19811 clearance
• 19801 clearance
• 19771 clearance

• Sage Products, Inc.2 clearances
• Preventive Diagnostics Corp.2 clearances
• Xsirius Medical, Inc.1 clearance
• Richard-Allan Medical Ind., Inc.1 clearance
• Perkins Mfg. Co.1 clearance
• M.M. Wolfred, Ph.D.1 clearance
• Hospal Medical Corp.1 clearance
• Dynatech Corp.1 clearance
• Biosure, Inc.1 clearance
• American Scientific Products1 clearance

• K873593 — BIOSURE SPECIMEN COLLECTION CONTAINERBiosure, Inc.·1987-11-25
• K862665 — NOVACYTE-UXsirius Medical, Inc.·1986-09-04
• K834579 — BIOSPAL 2400SHospal Medical Corp.·1984-02-04
• K834412 — PRESERV PVA FIXATIVE 15ML-FORMALIN PKPreventive Diagnostics Corp.·1984-01-13
• K833660 — PRESERV PVA FIXATIVE -MALIN PACKPreventive Diagnostics Corp.·1983-11-28
• K823773 — PROVIAL II #006-010-0201Dynatech Corp.·1983-01-21
• K822870 — STOOL-COLLECTION/PRESERVATION KITAmerican Scientific Products·1982-11-01
• K821621 — PREGNOPOSTM.M. Wolfred, Ph.D.·1982-07-21
• K820246 — PREFILLED SPECIMEN CONTAINERSage Products, Inc.·1982-02-18
• K811793 — FIX-RIGHT 90ML & 180 ML PREFILLED CONTRichard-Allan Medical Ind., Inc.·1981-07-31
• K800946 — URINARY CATHETER SAMPLING KITSage Products, Inc.·1980-06-20
• K770071 — PINLOCK CONTAINERPerkins Mfg. Co.·1977-02-24