The following data is part of a premarket notification filed by Diagnostic Technology, Inc. with the FDA for Ebv/vca-check(tm) Antigen Slides.
Device ID | K863408 |
510k Number | K863408 |
Device Name: | EBV/VCA-CHECK(TM) ANTIGEN SLIDES |
Classification | Antiserum, Cf, Epstein-barr Virus |
Applicant | DIAGNOSTIC TECHNOLOGY, INC. 240 VANDERBILT MOTOR PKWY. Hauppauge, NY 11788 |
Contact | Robert E Lind |
Correspondent | Robert E Lind DIAGNOSTIC TECHNOLOGY, INC. 240 VANDERBILT MOTOR PKWY. Hauppauge, NY 11788 |
Product Code | GNP |
CFR Regulation Number | 866.3235 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-09-03 |
Decision Date | 1986-11-28 |