The following data is part of a premarket notification filed by The Binding Site, Ltd. with the FDA for Rit Liver, Kidney, Stomach Ifa Kit.
| Device ID | K955431 |
| 510k Number | K955431 |
| Device Name: | RIT LIVER, KIDNEY, STOMACH IFA KIT |
| Classification | Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control |
| Applicant | THE BINDING SITE, LTD. EAST TOWER, SUITE 600 2425 WEST OLYMPIC BOULEVARD Santa Monica, CA 90404 |
| Contact | Jay H Geller |
| Correspondent | Jay H Geller THE BINDING SITE, LTD. EAST TOWER, SUITE 600 2425 WEST OLYMPIC BOULEVARD Santa Monica, CA 90404 |
| Product Code | DBL |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-28 |
| Decision Date | 1996-04-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08426950545798 | K955431 | 000 |
| 08426950514176 | K955431 | 000 |