The following data is part of a premarket notification filed by American Bionetics, Inc. with the FDA for Wesblot Processor.
Device ID | K874887 |
510k Number | K874887 |
Device Name: | WESBLOT PROCESSOR |
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 | 1987-12-01 |
Decision Date | 1988-03-24 |