The following data is part of a premarket notification filed by Gen Trak, Inc. with the FDA for Monoclonal Antibody Igg2a Isotype Cont. Flow Cytom.
| Device ID | K922085 |
| 510k Number | K922085 |
| Device Name: | MONOCLONAL ANTIBODY IGG2A ISOTYPE CONT. FLOW CYTOM |
| Classification | Counter, Differential Cell |
| Applicant | GEN TRAK, INC. 5100 CAMPUS DR. Plymouth Meeting, PA 19462 |
| Contact | Deborah L Lindemuth |
| Correspondent | Deborah L Lindemuth GEN TRAK, INC. 5100 CAMPUS DR. Plymouth Meeting, PA 19462 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-04 |
| Decision Date | 1992-07-28 |