ADENOCLONE(R)-TYPE 40/41 EIA DIAGNOSTIC TEST (48)

Antigens, Cf (including Cf Control), Adenovirus 1-33

CAMBRIDGE BIOSCIENCE CORP.

The following data is part of a premarket notification filed by Cambridge Bioscience Corp. with the FDA for Adenoclone(r)-type 40/41 Eia Diagnostic Test (48).

Pre-market Notification Details

• Device ID: K881894
• 510k Number: K881894
• Device Name: ADENOCLONE(R)-TYPE 40/41 EIA DIAGNOSTIC TEST (48)
• Classification: Antigens, Cf (including Cf Control), Adenovirus 1-33
• Applicant: CAMBRIDGE BIOSCIENCE CORP. 365 PLANTATION ST. Worcester, MA 01605
• Contact: Jack Cassorla
• Correspondent: Jack Cassorla; CAMBRIDGE BIOSCIENCE CORP. 365 PLANTATION ST. Worcester, MA 01605
• Product Code: GOD
• CFR Regulation Number: 866.3020 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1988-05-05
• Decision Date: 1988-07-08

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00840733101748	K881894	000