The following data is part of a premarket notification filed by The Binding Site, Ltd. with the FDA for Al-acid Glycoprotein Rid Kit.
| Device ID | K922417 |
| 510k Number | K922417 |
| Device Name: | AL-ACID GLYCOPROTEIN RID KIT |
| Classification | Alpha-1-acid-glycoprotein, Antigen, Antiserum, Control |
| Applicant | THE BINDING SITE, LTD. WESTSIDE TOWERS, SUITE 1000 11845 WEST OLYMPIC BLVD. Los Angeles, CA 90064 |
| Contact | Jay H Geller |
| Correspondent | Jay H Geller THE BINDING SITE, LTD. WESTSIDE TOWERS, SUITE 1000 11845 WEST OLYMPIC BLVD. Los Angeles, CA 90064 |
| Product Code | LKL |
| CFR Regulation Number | 866.5420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-21 |
| Decision Date | 1992-08-20 |