Product code CZJ— Immunology

FDA has cleared 8 devices under product code CZJ between 1978 and 2009, filed by 6 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20091 clearance
• 20051 clearance
• 20001 clearance
• 19911 clearance
• 19881 clearance
• 19871 clearance
• 19831 clearance
• 19781 clearance

• The Binding Site, Ltd.3 clearances
• The Binding Site1 clearance
• Kent Laboratories, Inc.1 clearance
• Kallestad Diag, A Div. of Erbamont, Inc.1 clearance
• Hyland Therapeutic Div., Travenol Laboratories1 clearance
• Helena Laboratories1 clearance

• K092450 — HUMAN IGD KIT FOR USE ON SPAPLUSThe Binding Site·2009-12-28
• K051299 — IGD DIAGNOSTIC TEST KITSThe Binding Site, Ltd.·2005-11-23
• K002561 — SHEEP ANTI-HUMAN IGD IMMUNOFIXATION GRADE KITThe Binding Site, Ltd.·2000-10-26
• K913671 — HUMAN IGD IMMUNOLOGICAL NL TEST KITThe Binding Site, Ltd.·1991-12-02
• K883001 — QM300 CALIBRATOR D PACKKallestad Diag, A Div. of Erbamont, Inc.·1988-09-22
• K872834 — TITAN GEL IFE ANTISERUM TO IGD-9409 & IGE-9410Helena Laboratories·1987-08-12
• K831956 — DETERM. SIZE 72 RADIAL-HUMAN IGDKent Laboratories, Inc.·1983-07-18
• K772327 — LAS-R HUMAN IGD TESTHyland Therapeutic Div., Travenol Laboratories·1978-02-28