The following data is part of a premarket notification filed by Diagnostic Technology, Inc. with the FDA for Hsv-check(tm) Test Kit.
Device ID | K890819 |
510k Number | K890819 |
Device Name: | HSV-CHECK(TM) TEST KIT |
Classification | Condom |
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 | HIS |
CFR Regulation Number | 884.5300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-02-17 |
Decision Date | 1989-06-20 |