The following data is part of a premarket notification filed by Diagnostic Technology, Inc. with the FDA for Ebna-check(tm) Test Kit.
| Device ID | K891542 |
| 510k Number | K891542 |
| Device Name: | EBNA-CHECK(TM) TEST KIT |
| Classification | Test, Antigen, Nuclear, 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 | LLM |
| CFR Regulation Number | 866.3235 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-17 |
| Decision Date | 1989-06-20 |