The following data is part of a premarket notification filed by Intl. Cancer Screening Laboratories, Inc. with the FDA for Diversi-kit.
Device ID | K882485 |
510k Number | K882485 |
Device Name: | DIVERSI-KIT |
Classification | Device, Specimen Collection |
Applicant | INTL. CANCER SCREENING LABORATORIES, INC. 3370 NACOGDOCHES RD., STE. 100 San Antonio, TX 78217 |
Contact | Boughton, Iii |
Correspondent | Boughton, Iii INTL. CANCER SCREENING LABORATORIES, INC. 3370 NACOGDOCHES RD., STE. 100 San Antonio, TX 78217 |
Product Code | LIO |
CFR Regulation Number | 866.2900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-06-16 |
Decision Date | 1988-07-18 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
DIVERSI-KIT 73757512 1551580 Dead/Cancelled |
INTERNATIONAL CANCER SCREENING LABORATORIES, INC. 1988-10-14 |