The following data is part of a premarket notification filed by Diagnostic Technology, Inc. with the FDA for Ebv/ea-check Tm Test Kit.
Device ID | K903612 |
510k Number | K903612 |
Device Name: | EBV/EA-CHECK TM TEST KIT |
Classification | Epstein-barr Virus, Other |
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 | LSE |
CFR Regulation Number | 866.3235 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-08-09 |
Decision Date | 1990-10-16 |