The following data is part of a premarket notification filed by The Cancer Center At Wadley Institutes with the FDA for Soc Slide Culture System.
Device ID | K882371 |
510k Number | K882371 |
Device Name: | SOC SLIDE CULTURE SYSTEM |
Classification | Kit, Screening, Yeast |
Applicant | THE CANCER CENTER AT WADLEY INSTITUTES 9000 HARRY HINES BLVD. Dallas, TX 75235 |
Contact | Dorn, Phd |
Correspondent | Dorn, Phd THE CANCER CENTER AT WADLEY INSTITUTES 9000 HARRY HINES BLVD. Dallas, TX 75235 |
Product Code | JXC |
CFR Regulation Number | 866.2660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-06-08 |
Decision Date | 1988-07-18 |