The following data is part of a premarket notification filed by American Bionetics, Inc. with the FDA for Versablot.
Device ID | K884258 |
510k Number | K884258 |
Device Name: | VERSABLOT |
Classification | Slide Stainer, Automated |
Applicant | AMERICAN BIONETICS, INC. 21377 CABOT BLVD. Hayward, CA 94545 |
Contact | Frank R Ruderman |
Correspondent | Frank R Ruderman AMERICAN BIONETICS, INC. 21377 CABOT BLVD. Hayward, CA 94545 |
Product Code | KPA |
CFR Regulation Number | 864.3800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-10-11 |
Decision Date | 1988-12-14 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
VERSABLOT 74104040 1669247 Dead/Cancelled |
BIOGENEX LABORATORIES 1990-10-09 |