The following data is part of a premarket notification filed by The Binding Site, Ltd. with the FDA for Human Igg Subclass Liquid Reagent Kits For Use On The Hitachi 911/7070 Turbidimetric Analyser.
| Device ID | K021081 |
| 510k Number | K021081 |
| Device Name: | HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE HITACHI 911/7070 TURBIDIMETRIC ANALYSER |
| Classification | Igg (gamma Chain Specific), Antigen, Antiserum, Control |
| Applicant | THE BINDING SITE, LTD. WEST TOWER, SUITE 4000 2425 WEST OLYMPIC BOULEVARD Santa Monica, CA 90404 |
| Contact | Jay H Geller |
| Correspondent | Jay H Geller THE BINDING SITE, LTD. WEST TOWER, SUITE 4000 2425 WEST OLYMPIC BOULEVARD Santa Monica, CA 90404 |
| Product Code | DFZ |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-03 |
| Decision Date | 2002-06-17 |