Product code JCE— Pathology

FDA has cleared 7 devices under product code JCE between 1977 and 1984, filed by 6 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.

• 19841 clearance
• 19831 clearance
• 19801 clearance
• 19791 clearance
• 19773 clearances

• Bio/Data Corp.2 clearances
• Nobel Scientific Industries, Inc.1 clearance
• Emd Chemicals, Inc.1 clearance
• E K Ind., Inc.1 clearance
• Coulter Electronics, Inc.1 clearance
• Central Labs. Assoc. MD Pathologists1 clearance

• K842722 — BUFFERED SALINEE K Ind., Inc.·1984-09-11
• K831200 — IMMUNOHEMATOLOGICAL SALINE #97139Emd Chemicals, Inc.·1983-05-09
• K801506 — CERTIFIED BLOOD BANK SALINENobel Scientific Industries, Inc.·1980-07-28
• K792101 — COUITER/CMS ISOTONIC BLOOD BANK SALINECoulter Electronics, Inc.·1979-11-20
• K761183 — LYSING AGENT AFCentral Labs. Assoc. MD Pathologists·1977-01-17
• K761170 — BARBITAL SALINE BUFFERBio/Data Corp.·1977-01-10
• K761174 — PHYSIOLOGIC SALINE (0.85%)Bio/Data Corp.·1977-01-10