The following data is part of a premarket notification filed by Hoffmann-la Roche, Inc. with the FDA for Sensi-slide.
Device ID | K792657 |
510k Number | K792657 |
Device Name: | SENSI-SLIDE |
Classification | Agglutination Method, Human Chorionic Gonadotropin |
Applicant | HOFFMANN-LA ROCHE, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JHJ |
CFR Regulation Number | 862.1155 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-12-26 |
Decision Date | 1980-01-16 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SENSI-SLIDE 73292854 1205899 Dead/Cancelled |
Hoffmann-La Roche Inc. 1981-01-12 |