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 |