K021081 is an FDA 510(k) clearance for the HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE HITACHI 911/7070 TURBIDIMETRIC ANALYSER. This device is classified as a Igg (gamma Chain Specific), Antigen, Antiserum, Control (Class II - Special Controls, product code DFZ).
Submitted by The Binding Site, Ltd. (Santa Monica, US). The FDA issued a Cleared decision on June 17, 2002, 75 days after receiving the submission on April 3, 2002.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5510.
| 510(k) Number | K021081 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 03, 2002 |
| Decision Date | June 17, 2002 |
| Days to Decision | 75 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | DFZ — Igg (gamma Chain Specific), Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5510 |