EBV TEST

Antiserum, Cf, Epstein-barr Virus

GULL LABORATORIES, INC.

The following data is part of a premarket notification filed by Gull Laboratories, Inc. with the FDA for Ebv Test.

Pre-market Notification Details

• Device ID: K771062
• 510k Number: K771062
• Device Name: EBV TEST
• Classification: Antiserum, Cf, Epstein-barr Virus
• Applicant: GULL LABORATORIES, INC. UT
• Product Code: GNP
• CFR Regulation Number: 866.3235 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1977-06-13
• Decision Date: 1977-07-14

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00840733101939	K771062	000