IMAGEN

Antigens, Cf (including Cf Control), Parainfluenza Virus 1-4

DAKO DIAGNOSTICS LTD.

The following data is part of a premarket notification filed by Dako Diagnostics Ltd. with the FDA for Imagen.

Pre-market Notification Details

• Device ID: K943557
• 510k Number: K943557
• Device Name: IMAGEN
• Classification: Antigens, Cf (including Cf Control), Parainfluenza Virus 1-4
• Applicant: DAKO DIAGNOSTICS LTD. DENMARK HOUSE, ANGEL DROVE, ELY Cambridgeshire, GB Cb7 4et
• Contact: Elisabeth A Johnson-proctor
• Correspondent: Elisabeth A Johnson-proctor; DAKO DIAGNOSTICS LTD. DENMARK HOUSE, ANGEL DROVE, ELY Cambridgeshire, GB Cb7 4et
• Product Code: GQS
• CFR Regulation Number: 866.3400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-07-22
• Decision Date: 1995-01-09