The following data is part of a premarket notification filed by American Bionetics, Inc. with the FDA for Wesblot Rnp-sm Test.
| Device ID | K881379 |
| 510k Number | K881379 |
| Device Name: | WESBLOT RNP-SM TEST |
| Classification | Anti-sm Antibody, Antigen And Control |
| 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 | LKP |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-01 |
| Decision Date | 1988-05-16 |