Product code DDX— Immunology

FDA has cleared 10 devices under product code DDX between 1978 and 1994, 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.

• 19941 clearance
• 19891 clearance
• 19862 clearances
• 19851 clearance
• 19831 clearance
• 19812 clearances
• 19782 clearances

• Wellcome Diagnostics1 clearance
• Warner-Lambert Co.1 clearance
• The Binding Site, Ltd.1 clearance
• Kabivitrum, Inc.1 clearance
• Instrumentation Laboratory CO1 clearance
• Hyland Therapeutic Div., Travenol Laboratories1 clearance
• Helena Laboratories1 clearance
• E.I. Dupont DE Nemours & Co., Inc.1 clearance
• Dade, Baxter Travenol Diagnostics, Inc.1 clearance
• Behring Diagnostics, Inc.1 clearance

• K941346 — PLASMINOGEN RID TEST KITThe Binding Site, Ltd.·1994-09-09
• K884766 — BERICHROM(R) PLASMINOGENBehring Diagnostics, Inc.·1989-01-04
• K864212 — IL TEST 97573-15, PLASMINOGEN ASSAYInstrumentation Laboratory CO·1986-12-04
• K854572 — COATEST PLASMINOGENKabivitrum, Inc.·1986-02-26
• K850410 — GEN. DIAG. CHROMOSTRATE PLASMINOGEN ASSAYWarner-Lambert Co.·1985-05-08
• K832591 — DIACROM *PLGWellcome Diagnostics·1983-11-21
• K812625 — ACA PLASMINOGEN TEST PACKE.I. Dupont DE Nemours & Co., Inc.·1981-09-29
• K811777 — HELENA PLASMINOGEN QUIPLATE PROCEDUREHelena Laboratories·1981-07-02
• K781478 — PLASMINOGEN ASSAYDade, Baxter Travenol Diagnostics, Inc.·1978-11-15
• K772085 — LAS-R HUMAN PLASMINOGEN TESTHyland Therapeutic Div., Travenol Laboratories·1978-01-24